melphalan (Rx)

Brand and Other Names:Evomela, Hepzato, more...Alkeran (DSC)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 50mg (Evomela, generic)

injection, lyophilized powder for reconstitution for intrahepatic administration

  • 50mg (Hepzato Kit [drug plus supplied diluents])

tablet

  • 2mg (generic)

Multiple Myeloma

Palliative treatment

  • Tablets only: Indicated for palliative treatment of patients with multiple myeloma (MM)
  • 6 mg PO qDay for 2-3 weeks, OR
  • 10 mg PO qDay for 7-10 days, OR
  • 0.15 mg/kg/day PO for 7 days, THEN
  • After adequate recovery from toxicity (monitor WBCs and platelets) give 1-3 mg or 0.05 mg/kg PO qDay

Conditioning treatment

  • Indicated for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with MM
  • 100 mg/m²/day IV administered over 30 min for 2 consecutive days (Day -3 and Day -2) prior to autologous stem cell transplantation (ASCT, Day 0)  
  • Patients weighing >130% of their ideal body weight, body surface area should be calculated based on adjusted ideal body weight

Ovarian Cancer

Indicated for palliative treatment of nonresectable epithelial ovarian carcinoma

0.2 mg/kg/day PO for 5 days; repeat q4-5Weeks depending on hematologic tolerance  

Uveal Melanoma with Hepatic Metastases

Indicated as a liver-directed treatment for adults with uveal melanoma with unresectable hepatic metastases affecting <50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation

Before procedure

  • Discontinue oral anticoagulation and drugs affecting platelet function
  • Discontinue ACE-inhibitors, calcium channel blockers, or alpha-1-adrenergic blockers
  • Conduct baseline hematologic testing
    • Hemoglobin ≥10 g/dL
    • Platelets ≥100,000/mcL
    • Neutrophils >2,000/mcL

Dosage

  • Administer only to patients weighing >35 kg owing to potential size limitations with respect to percutaneous catheterization
  • 3 mg/kg (ideal body weight [IBW]) via hepatic artery q6-8Weeks for up to 6 total infusions; not to exceed 220 mg/single treatment
  • Men IBW calculation
    • Height ≥152 cm: 52 kg + (0.75 kg/cm of height >152 cm)
    • Height <152 cm: 52 kg – (0.75 kg/cm of height <152 cm)
  • Women IBW calculation
    • Height ≥152 cm: 49 kg + (0.67 kg/cm of height >152 cm)
    • Height <152 cm: 49 kg – (0.67 kg/cm of height <152 cm)

Dosage Modifications

Renal impairment (BUN ≥30 mg/dL): Consider dosage reduction of up to 50%

Hepzato adverse effects

  • Reduce dose to 2 mg/kg for subsequent treatments if
    • Grade 4 neutropenia of >5 days duration despite growth factor support or associated with neutropenic fever
    • Grade 4 thrombocytopenia of >5 days duration or associated with a hemorrhage that required a transfusion
  • Discontinue if
    • Patients have life threatening or melphalan-related persistent toxicity that has not resolved to Grade ≤2 by 8 weeks following treatment

Dosing Considerations

Verify pregnancy status of females of reproductive potential before initiating

Double balloon catheter component of melphalan intra-arterial hepatic infusion kit (Hepzato) contains natural rubber latex

Orphan Designations

Stem cell transplantation

  • High dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation
  • Orphan sponsor: CyDex Pharmaceuticals, Inc; 10513 W. 84th Terrace; Lenexa, KS 66214

Cutaneous melanoma

  • Sponsor: Delcath Systems, Inc; 1301 Avenue of the Americas, 43rd Floor; New York, NY 10019

Hepatocellular cancer

  • Sponsor: Delcath Systems, Inc; 1301 Avenue of the Americas, 43rd Floor; New York, NY 10019

Ocular (uveal) melanoma

  • Sponsor: Delcath Systems, Inc; 1301 Avenue of the Americas, 43rd Floor; New York, NY 10019

Neuroendocrine tumors

  • Sponsor: Delcath Systems, Inc; 1301 Avenue of the Americas, 43rd Floor; New York, NY 10019

Retinoblastoma

  • Intraocular injection
  • Sponsor: Icon Bioscience, Inc; 1253 Reamwood Ave; Sunnyvale, CA 94089

Cholangiocarcinoma

  • Sponsor: Delcath Systems, Inc; 1301 Avenue of the Americas, 43rd Floor; New York, NY 10019

Other Indications & Uses

Off-label: Breast cancer, testicular cancer, melanoma

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and melphalan

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (15)

            • adenovirus types 4 and 7 live, oral

              melphalan decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • BCG vaccine live

              melphalan decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • cholera vaccine

              melphalan decreases effects of cholera vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • influenza virus vaccine quadrivalent, intranasal

              melphalan decreases effects of influenza virus vaccine quadrivalent, intranasal by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • measles (rubeola) vaccine

              melphalan decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • measles mumps and rubella vaccine, live

              melphalan decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • measles, mumps, rubella and varicella vaccine, live

              melphalan decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • rotavirus oral vaccine, live

              melphalan decreases effects of rotavirus oral vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • rubella vaccine

              melphalan decreases effects of rubella vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • smallpox (vaccinia) vaccine, live

              melphalan decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • typhoid polysaccharide vaccine

              melphalan decreases effects of typhoid polysaccharide vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • typhoid vaccine live

              melphalan decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • varicella virus vaccine live

              melphalan decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • yellow fever vaccine

              melphalan decreases effects of yellow fever vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            • zoster vaccine live

              melphalan decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo. after cessation of immunosuppressive therapy.

            Serious - Use Alternative (14)

            • axicabtagene ciloleucel

              melphalan, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • brexucabtagene autoleucel

              melphalan, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • ciltacabtagene autoleucel

              melphalan, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • idecabtagene vicleucel

              melphalan, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • lisocabtagene maraleucel

              melphalan, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • natalizumab

              melphalan, natalizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

            • nivolumab

              melphalan, nivolumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of immunosuppressants (eg, systemic corticosteroids) prior to initiation of nivolumab. Use of immunosuppressants after administration of nivolumab (eg, for treatment of immune-related adverse reactions) is unlikely to affect nivolumab efficacy.

            • ocrelizumab

              melphalan, ocrelizumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

            • palifermin

              palifermin increases toxicity of melphalan by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • pimecrolimus

              melphalan, pimecrolimus. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

            • ropeginterferon alfa 2b

              ropeginterferon alfa 2b, melphalan. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.

            • tacrolimus

              melphalan, tacrolimus. Either decreases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

            • tisagenlecleucel

              melphalan, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

            • tofacitinib

              melphalan will increase the level or effect of tofacitinib by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use in combination with potent immunosuppressants; concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Agents considered as potent immunosuppressants are not specified, but lower corticosteroid doses (ie, equivalent to prednisone 10 mg/day or less), leflunomide, and antirheumatic doses of methotrexate were permitted in clinical studies.

            Monitor Closely (55)

            • amphotericin B cholesteryl sulfate

              melphalan increases toxicity of amphotericin B cholesteryl sulfate by unknown mechanism. Use Caution/Monitor. Monitor for possible increases in renal toxicity, bronchospasm, and hypotension if amphotericin is given concomitantly with melphalan.

            • amphotericin B deoxycholate

              melphalan increases toxicity of amphotericin B deoxycholate by unknown mechanism. Use Caution/Monitor. Monitor for possible increases in renal toxicity, bronchospasm, and hypotension if amphotericin is given concomitantly with melphalan.

            • amphotericin B liposomal

              melphalan increases toxicity of amphotericin B liposomal by unknown mechanism. Use Caution/Monitor. Monitor for possible increases in renal toxicity, bronchospasm, and hypotension if amphotericin is given concomitantly with melphalan.

            • amphotericin B phospholipid complex

              melphalan increases toxicity of amphotericin B phospholipid complex by unknown mechanism. Use Caution/Monitor. Monitor for possible increases in renal toxicity, bronchospasm, and hypotension if amphotericin is given concomitantly with melphalan.

            • anthrax vaccine adsorbed

              melphalan decreases effects of anthrax vaccine adsorbed by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • belatacept

              belatacept and melphalan both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • bendamustine

              bendamustine, melphalan. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Additive myelosuppression.

            • cyclosporine

              melphalan, cyclosporine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Melphalan may enhance the nephrotoxic effects of cyclosporine. Monitor for increased nephrotoxicity in cyclosporine-treated patient who receive melphalan.

              melphalan increases toxicity of cyclosporine by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

            • dengue vaccine

              melphalan decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • denosumab

              melphalan, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              melphalan, denosumab. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • diphtheria & tetanus toxoids

              melphalan decreases effects of diphtheria & tetanus toxoids by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • diphtheria & tetanus toxoids/ acellular pertussis vaccine

              melphalan decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine

              melphalan decreases effects of diphtheria & tetanus toxoids/acellular pertussis/poliovirus, inactivated vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • echinacea

              echinacea decreases effects of melphalan by Other (see comment). Use Caution/Monitor. Comment: Echinacea is reported possess immunostimulatory activity demonstrated by activation of macrophages (releasing interleukin-1), and proliferation of B-lymphocytes; theoretically, may oppose the therapeutic effects of immunosuppressants.

            • fingolimod

              melphalan increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • haemophilus influenzae type b vaccine

              melphalan decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

            • hepatitis A vaccine inactivated

              melphalan decreases effects of hepatitis A vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • hepatitis a/b vaccine

              melphalan decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • hepatitis b vaccine

              melphalan decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • HIV vaccine

              melphalan decreases effects of HIV vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • human papillomavirus vaccine, nonavalent

              melphalan decreases effects of human papillomavirus vaccine, nonavalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • human papillomavirus vaccine, quadrivalent

              melphalan decreases effects of human papillomavirus vaccine, quadrivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • hydroxyurea

              melphalan, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

            • influenza A (H5N1) vaccine

              melphalan decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine (H5N1), adjuvanted

              melphalan decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine quadrivalent

              melphalan decreases effects of influenza virus vaccine quadrivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine quadrivalent, adjuvanted

              melphalan decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine quadrivalent, cell-cultured

              melphalan decreases effects of influenza virus vaccine quadrivalent, cell-cultured by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine quadrivalent, recombinant

              melphalan decreases effects of influenza virus vaccine quadrivalent, recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine trivalent

              melphalan decreases effects of influenza virus vaccine trivalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine trivalent, adjuvanted

              melphalan decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • influenza virus vaccine trivalent, recombinant

              melphalan decreases effects of influenza virus vaccine trivalent, recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • isavuconazonium sulfate

              melphalan and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.

            • Japanese encephalitis virus vaccine

              melphalan decreases effects of Japanese encephalitis virus vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • leflunomide

              melphalan, leflunomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Monitor for bone marrow suppression at least monthly in patients concomitantly using leflunomide and another immunosuppressant.

            • meningococcal A C Y and W-135 diphtheria conjugate vaccine

              melphalan decreases effects of meningococcal A C Y and W-135 diphtheria conjugate vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • meningococcal A C Y and W-135 polysaccharide vaccine combined

              melphalan decreases effects of meningococcal A C Y and W-135 polysaccharide vaccine combined by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • meningococcal group B vaccine

              melphalan decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • ofatumumab SC

              ofatumumab SC, melphalan. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • oxaliplatin

              oxaliplatin, melphalan. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of myelosuppression.

            • pneumococcal vaccine 13-valent

              melphalan decreases effects of pneumococcal vaccine 13-valent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • pneumococcal vaccine heptavalent

              melphalan decreases effects of pneumococcal vaccine heptavalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • pneumococcal vaccine polyvalent

              melphalan decreases effects of pneumococcal vaccine polyvalent by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • poliovirus vaccine inactivated

              melphalan decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .

            • rabies vaccine

              melphalan decreases effects of rabies vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • rabies vaccine chick embryo cell derived

              melphalan decreases effects of rabies vaccine chick embryo cell derived by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • roflumilast

              roflumilast will increase the level or effect of melphalan by immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

            • siponimod

              siponimod and melphalan both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              melphalan decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              melphalan decreases effects of sipuleucel-T by immunosuppressive effects; risk of infection. Use Caution/Monitor. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects.

            • tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine

              melphalan decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • tetanus toxoid adsorbed or fluid

              melphalan decreases effects of tetanus toxoid adsorbed or fluid by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            • trastuzumab

              trastuzumab, melphalan. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, melphalan. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              melphalan, trastuzumab deruxtecan. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Closely monitor for neutropenia and/or anemia when trastuzumab is used in combination with immunosuppressant agents (particularly with myelosuppressive chemotherapy agents).

            • voclosporin

              voclosporin, melphalan. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.

            • zoster vaccine recombinant

              melphalan decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

            Minor (4)

            • digoxin

              melphalan will decrease the level or effect of digoxin by Other (see comment). Minor/Significance Unknown. Antineoplastic agents that cause significant mucositis/stomatitis may be more likely to impair digoxin tablet absorption

            • ibuprofen/famotidine

              ibuprofen/famotidine decreases levels of melphalan by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • vitamin A

              vitamin A, melphalan. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

            • vitamin E

              vitamin E, melphalan. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

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            Adverse Effects

            >10%

            Myelosuppression (30%)

            Frequency Not Defined

            Nausea

            Vomiting

            Interstitial pneumonia

            Pulmonary fibrosis

            Diarrhea

            Stomatitis

            Mucositis

            Secondary malignancy

            Hypersensitivity reaction

            Tissue necrosis

            Jaundice

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            Warnings

            Black Box Warnings

            Bone marrow suppression, hypersensitivity, and leukemogenicity

            • Administer under the supervision of an experienced cancer chemotherapy physician
            • Severe bone marrow suppression may occur resulting in bleeding and infection
            • Hypersensitivity reactions, including anaphylaxis, reported
            • Melphalan is leukemogenic and potentially mutagenic (carcinogenic) in humans

            Intra-hepatic administration complications

            • Severe periprocedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur
            • Assess patients for these adverse reactions during and for 72 hr following administration
            • REMS
              • Only available through restricted program under a Risk Evaluation and Mitigation Strategy (REMS), owing to risk of severe periprocedural complications including hemorrhage, hepatocellular injury, and thromboembolic events
              • Healthcare providers must complete the required HEPZATO KIT REMS training before administration
              • Healthcare settings that dispense and administer intra-hepatic melphalan must be enrolled, certified, and comply with REMS requirements
              • Certified healthcare facilities must ensure that healthcare providers who perform percutaneous hepatic perfusion (PHP) procedure are trained on of intra-hepatic melphalan and must only dispense Hepzato when authorized to do so by the REMS
              • Certified healthcare facilities must ensure patients are assessed for severe periprocedural complications during the procedure and for at least 72 hr afterwards
              • Additional information available at 1-833-632-0457

            Contraindications

            Hypersensitivity to melphalan or chlorambucil

            Prior resistance to melphalan

            Hepzato periprocedural risks

            • Active intracranial metastases or brain lesions with a propensity to bleed
            • Liver failure, portal hypertension, or known varices at risk for bleeding
            • Surgery or medical treatment of liver in previous 4 weeks
            • Uncorrectable coagulopathy
            • Inability to safely undergo general anesthesia, including active cardiac conditions including, but not limited to, unstable coronary syndromes (unstable or severe angina or myocardial infarction), worsening or new-onset
            • CHF, significant arrhythmias, or severe valvular disease
            • History of allergies/hypersensitivity to components in kit, including
              • Melphalan
              • Natural rubber latex
              • Heparin or presence of heparin-induced thrombocytopenia (HIT)
              • Iodinated contrast not controlled by premedication with antihistamines and steroids

            Cautions

            Based on its mechanism of action, can cause fetal harm when administered to pregnant females

            Reported to cause suppression of ovarian function in premenopausal women, resulting in persistent amenorrhea

            Myelosuppression

            • If receiving melphalan as part of a conditioning regimen, myeloablation occurs in all patients
            • Do not begin conditioning regimen if a stem cell product is not available for rescue
            • Monitor CBC counts, provide supportive care for infections, anemia, and thrombocytopenia until there is adequate hematopoietic recovery

            Gastrointestinal toxicity

            • Nausea, vomiting, mucositis, and diarrhea often occurs
            • Use prophylactic antiemetic medication (eg, PPI before initiating)
            • Provide supportive care for nausea, vomiting, diarrhea, and mucositis
            • Provide nutritional support and analgesics for patients with severe mucositis

            Hepatotoxicity

            • Hepatic disorders ranging from abnormal liver function tests to clinical manifestations (eg, hepatitis, jaundice) reported
            • Hepatic veno-occlusive disease also reported
            • Monitor liver chemistries

            Hypersensitivity

            • Acute hypersensitivity reactions, including anaphylaxis, reported
            • Symptoms may include urticaria, pruritus, edema, and skin rashes and, in some patients, tachycardia, bronchospasm, dyspnea, and hypotension
            • Discontinue treatment for serious hypersensitivity reactions

            Secondary malignancies

            • Shown to cause chromatid or chromosome damage in humans
            • Secondary malignancies (eg, myeloproliferative syndrome, acute leukemia) reported in patients with multiple myeloma treated with melphalan-containing regimens
            • otential benefit of therapy must be considered against possible risk of inducting a secondary malignancy

            Periprocedural risks with intrahepatic administration (Hepzato)

            • Hemorrhage, hepatocellular injury, and thromboembolic events observed when melphalan has been administered via hepatic intra-arterial administration
            • Administration requires general anesthesia and extracorporeal bypass of circulation, which may cause life threatening or fatal adverse effects
            • Ensure patient is euvolemic, but do not overhydrate
            • Monitor for these complications during procedure and for at least 72 hr afterwards
            • Mitigate thromboembolic risk by administering anticoagulation as described in the instruction during the procedure
            • Owing to bleeding risk, do not use in patients with uncorrectable coagulopathies and delay treatment for at least 4 weeks after surgery or other medical procedures involving the liver
            • Platelets and clotting factors may be removed during intra-hepatic procedure
            • Monitor platelets and coagulation parameters
            • Patients with abnormal hepatic vascular (especially arterial supply) or biliary (especially reimplantation of bile duct) anatomy or gastric acid hypersecretion syndromes may be at increased risk
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            Pregnancy & Lactation

            Pregnancy

            Based on mechanism of action, therapy can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality; product is a genotoxic drug and can cause chromatid or chromosome damage in humans

            Contraception

            • Females: Advise females of reproductive potential to use effective contraception during treatment and for 6 months after last dose
            • Males: Drug administration may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities; advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after last dose

            Infertility

            • Females: Therapy causes suppression of ovarian function in premenopausal women, resulting in amenorrhea in a significant number of patients
            • Males: Reversible and irreversible testicular suppression reported in males after administration

            Animal data

            • In animal studies, melphalan was embryolethal and teratogenic in rats at doses below recommended clinical doses; advise pregnant females of potential fetal risk

            Lactation

            It is not known whether drug is present in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing children from melphalan, breastfeeding is not recommended during treatment and for one week after last dose

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Mechorethamine derivative that inhibits DNA & RNA synthesis via formation of carbonium ions; cross links DNA strands (interstrand and intrastrand crosslinking) causing miscoding breakage and subsequently DNA replication failure

            Pharmacokinetics

            Peak plasma time: 2 hr

            Concentration: 280 ng/mL

            Half-Life: 60-120 min (oral), 75 min (IV)

            Bioavailability: 60-90%

            Vd: 0.5 L/kg

            Clearance: 7-9 mL/min/kg

            Excretion: Feces (20-50%); urine (10% as unchanged drug)

            Dialyzable: No

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            Administration

            IV Incompatibilities

            Solution: D5W, LR, NS (NS can be used in short time period)

            Y-site: amphotericin B, chlorpromazine

            IV Compatibilities

            Y-site (partial list): acyclovir, bleomycin, most cephalosporins, cisplatin, cyclophosphamide, cytarabine, dacarbazine, dactinomycin, daunorubicin, diphenhydramine, doxorubicin, floxuridine, fluconazole, fludarabine, fluorouracil, furosemide, granisetron, heparin, idarubicin, imipenem-cilastatin, lorazepam, methotrexate, metoclopramide, mitomycin, morphine SO4, ondansetron, KCl, prochlorperazine, promethazine, NaHCO3, teniposide, thiotepa, vancomycin, vinblastine, vincristine, vinorelbine, zidovudine

            IV Preparation

            Use chemotherapy precautions for handling, preparation, administration, and disposal

            Generic

            • Reconstitute lyophilized powder
              • Rapidly inject 10 mL of the supplied diluent directly into the vial containing lyophilized powder using a needle ≥20-gauge
              • Immediately shake vial vigorously until a clear solution is obtained
              • Dissolve powder initially with 10 mL of provided diluent to 5 mg/mL
              • This results in a 5-mg/mL solution
              • Rapid addition of the diluent followed by immediate vigorous shaking is important for proper dissolution
            • Immediately dilute further
              • Immediately dilute solution in 0.9% NaCl to concentration <0.45 mg/mL
              • Keep to a minimum (<60 min) time between reconstitution/dilution & administration
              • Do not refrigerate solution; precipitation occurs
              • Standard dilution: dose/250-500 mL 0.9% NaCl (concentration <0.45 mg/mL); must be prepared fresh

            Evomela

            • Reconstitute lyophilized powder
              • Captisol-enabled; propylene glycol-free product
              • Use 8.6 mL 0.9% NaCl to reconstitute vial contents (yields 50 mg/10 mL [5 mg/ mL] solution)
              • The normal saline used to reconstitute each vial should appear to be assisted or pulled into the vial by the negative pressure (partial vacuum) present in the vial; discard any vial (and replace with another vial) if there is no vacuum present when reconstituting the vial with normal saline
              • Reconstituted solution is stable for 24 hr refrigerated (5°C)without any precipitation due to the high solubility or for 1 hr at room temperature
            • Dilute further
              • Calculate the required volume of reconstituted solution needed for the dose and withdraw that volume from the vial(s)
              • Add the required dosage volume to the appropriate volume of 0.9% NaCl to a final concentration of 0.45 mg/mL
              • Admixture solution is stable for 4 hr at room temperature in addition to the 1 hr following reconstitution

            Intra-arterial Hepatic Preparation

            Compatibilities: 0.9% NaCl

            Heparin is a component of Hepatic Delivery System (HDS)

            Refer to prescribing information for additional instructions including pre-infusion evaluation, hydration, premedication, anticoagulation, and supportive care

            Caution: Double balloon catheter component of HDS contains natural rubber latex which may cause allergic reactions

            Healthcare providers must complete the required HEPZATO KIT REMS training before administering

            Reconstitution

            • Reconstitute and dilute melphalan immediately before beginning intra-arterial infusion
            • Reconstituted and diluted solutions are unstable
            • No more than 60 minutes should elapse from reconstitution and completion of intra-hepatic infusion of the diluted solution
            • A precipitate forms if reconstituted solution stored at 5°C; do not refrigerate once reconstituted
            • Hazardous drug: Follow applicable special handling and disposal procedures
            • Rapidly (in ≥5 seconds) inject 10 mL of supplied sterile diluent into the HEPZATO 50-mg vial using a sterile needle (≥20-gauge) and syringe; resulting concentration is 5 mg/mL
            • Immediately shake vial vigorously until a clear solution is obtained; no more 5 seconds should elapse between injecting diluent into vial and shaking the vial

            Dilution

            • Immediately further dilute the required dose with provided 0.9% NaCl, to a concentration ≤0.45mg/mL
            • Doses up to 110 mg: Dilute in 250-mL infusion bag of 0.9% NaCl
            • Doses 111-220 mg: Divide total dose (TD) equally into 2 and dilute each in 250-mL infusion bag of 0.9% NaCl (ie, if total dose is 200 mg, make 2 bags of 100 mg and dilute each 100-mg dose with 250-mL infusion bag of 0.9% NaCl)
            • Visually inspect drug products for particulate matter and discoloration before administering; discard if particulates and discolorations are noted

            IV Administration

            Administer prophylactic antiemetic agents

            Avoid skin contact with IV formulation

            Generic

            • IV infusion
              • FDA approved for administration as a single infusion over a minimum of 15-20 min
              • Complete administration within 60 min of reconstituting the lyophilized powder

            Evomela

            • Conditioning: Infuse IV over 30 minutes via an injection port or central venous catheter

            Intra-arterial Hepatic Administration

            Complete infusion within 30 minutes, followed by a 30-minute washout period

            Refer to prescribing information for additional administration procedures

            Oral Administration

            Take on empty stomach; oral administration with a high fat meal may reduce melphalan systemic exposure

            Storage

            Tablets or unopened vials

            • Protect from light; retain in original carton until use
            • Store at 20-25ºC (68-77ºF); excursions permitted to (15-30°C (59-86ºF)
            • Melphalan is a hazardous drug; follow applicable special handling and disposal procedures

            Hepzato Kit

            • Store at 20-25ºC (68-77ºF); excursions permitted to (15-30°C (59-86ºF)
            • Store in original carton until use to protect from light
            • Do not refrigerate drug or diluent solution
            • Use within 1 hr (from reconstitution to end of infusion)
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            melphalan oral
            -
            2 mg tablet
            Alkeran oral
            -
            2 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            melphalan oral

            MELPHALAN - ORAL

            (MEL-fa-lan)

            COMMON BRAND NAME(S): Alkeran

            WARNING: Although melphalan is used to treat cancer, it may rarely increase your risk of developing other cancers. Also, melphalan may cause a severe decrease in your blood cells, which lowers your ability to fight infections and increases the risk of anemia/bleeding problems. You may be more likely to get a serious (rarely fatal) infection or any infection you have may get worse. Tell your doctor right away if you develop unusual growths or lumps, swollen glands, signs of infection (such as a sore throat that doesn't go away, fever, chills), easy or unusual bruising/bleeding, or unusual tiredness.Taking melphalan during pregnancy may increase the risk of birth defects. Also, it may make it harder for men or women to have a child (decreased fertility) after treatment.Talk with your doctor about the risks and benefits of treatment with this medication.

            USES: This medication is used to treat certain types of cancer (such as multiple myeloma, ovarian). Melphalan belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

            HOW TO USE: Take this medication by mouth as directed by your doctor, usually once a day. Unless otherwise directed by your doctor, drink plenty of fluids to help prevent side effects.The dosage and treatment schedule are based on your medical condition and response to treatment. Carefully follow your doctor's directions for taking this medication.Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.It may take several months before you see a benefit from this drug.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

            SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, lip/mouth sores, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, such as: shortness of breath, stopped menstrual periods (women), symptoms of liver problems (such as stomach/abdominal pain, yellowing eyes/skin, dark urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking melphalan, tell your doctor or pharmacist if you are allergic to it; or to chlorambucil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding/blood problems, kidney problems, radiation treatment.Melphalan can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using melphalan before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using melphalan. Melphalan may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

            MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

            STORAGE: Store in the refrigerator away from light and moisture. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised March 2023. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.