ado-trastuzumab emtansine (Rx)

Brand and Other Names:Kadcyla
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/vial
  • 160mg/vial
  • 20mg/mL following reconstitution

Breast Cancer

Early breast cancer

  • Indicated as a single agent for adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment
  • 3.6 mg/kg IV q3Weeks
  • Do not administer at doses >3.6 mg/kg
  • Continue treatment for a total of 14 cycles unless there is disease recurrence or unacceptable toxicity

Metastatic breast cancer

  • Indicated as a single agent for treatment of HER2-positive, metastatic breast cancer (MBC) in patients who previously received trastuzumab and a taxane, separately or in combination, and have either received prior therapy for metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy
  • 3.6 mg/kg IV q3Weeks
  • Do not administer at doses >3.6 mg/kg
  • Continue until disease recurrence or unacceptable toxicity

Dosage Modifications

Dose reduction for adverse events

  • Do not re-escalate dose after reduction is made
  • First dose reduction: 3 mg/kg
  • Second dose reduction: 2.4 mg/kg
  • Requirement for further dose reduction: Discontinue treatment

Hepatotoxicity

  • MBC
    • Grade 2 (AST/ALT >2.5 to ≤5x ULN): Maintain same dose level
    • Grade 3 (AST/ALT >5 to ≤20x ULN): Do not administer until AST/ALT recovers to Grade ≤2, and then reduce 1 dose level
    • Grade 4 (AST/ALT >20x ULN): Permanently discontinue
  • EBC
    • Grade 2 (AST >3 to ≤5x ULN on day of treatment): Do not administer until AST recovers to Grade ≤1, and then maintain same dose level
    • Grade 2 or 3 (ALT >3 to ≤20x ULN) or Grade 3 (AST >5 to ≤20x ULN) on day of treatment: Do not administer until ALT/AST recovers to Grade ≤1, and then reduce 1 dose level
    • Grade 4 (AST/ALT >20x ULN at any time): Permanently discontinue

Hyperbilirubinemia

  • MBC
    • Grade 2 (total bilirubin >1.5 to ≤10x ULN): Do not administer until total bilirubin recovers to Grade ≤1, and then maintain same dose level
    • Grade 3 (total bilirubin >3 to ≤10x ULN): Do not administer until total bilirubin recovers to Grade≤1, and then reduce 1 dose level
    • Grade 4 (total bilirubin >10x ULN): Permanently discontinue
  • EBC
    • Total bilirubin >1 to ≤2x ULN on day of treatment: Do not administer until total bilirubin ≤1x ULN, and then reduce 1 dose level
    • Total bilirubin >2x ULN at any time: Permanently discontinue

Left ventricular dysfunction

  • MBC
    • LVEF <40%: Do not administer drug; repeat LVEF assessment within 3 weeks, if <40% confirmed, discontinue drug
    • LVEF 40% to ≤45% and decrease is ≥10% points from baseline: Do not administer drug; repeat LVEF assessment within 3 weeks; if LVEF has not recovered to within 10% points from baseline, discontinue drug
    • LVEF 40% to ≤45% and decrease is <10% points from baseline: Continue drug and repeat LVEF assessment within 3 weeks
    • LVEF >45%: Continue drug
  • EBC
    • LVEF <45%: Do not administer drug; repeat LVEF assessment within 3 weeks, if <45% confirmed, discontinue drug
    • LVEF 45% to <50% and decrease is ≥10% points from baseline: Do not administer drug; repeat LVEF assessment within 3 weeks, if LVEF remains <50% and has not recovered to <10% points from baseline, discontinue drug
    • LVEF 45% to <50% and decrease is <10% points from baseline: Continue drug and repeat LVEF assessment within 3 weeks
    • LVEF >50%: Continue treatment

Heart failure

  • MBC
    • Symptomatic CHF: Discontinue drug
  • EBC
    • Symptomatic CHF, Grade 3-4 LVSD or Grade 3-4 heart failure, or Grade 2 heart failure accompanied by LVEF < 45%: Discontinue treatment

Thrombocytopenia

  • MBC
    • Grade 3 (platelets 25,000/mm³ to ≤50,000/mm³): Do not administer until platelet count recovers to Grade ≤1 (ie, ≥75,000/mm³), and then maintain same dose level
    • Grade 4 (platelets <25,000/mm³): Do not administer until platelet count recovers to Grade ≤1 (ie, ≥75,000/mm³), and then reduce 1 dose level
  • EBC
    • Grade 3 (platelets 25,000/mm³ to ≤75,000/mm³ on day of treatment): Do not administer until platelet count recovers to Grade ≤1 (ie, ≥75,000/mm³), and then maintain same dose level; if patients requires 2 delays, consider reducing dose by 1 level
    • Grade 4 (platelets <25,000/mm³): Do not administer until platelet count recovers to Grade ≤1 (ie, ≥75,000/mm³), and then reduce 1 dose level

Pulmonary toxicity

  • Interstitial lung disease or pneumonitis: Permanently discontinue
  • Radiotherapy-related pneumonitis (EBC only)
    • Grade 2: Discontinue if not resolving with standard treatment
    • Grade 3-4: Discontinue treatment

Peripheral neuropathy

  • Grade 3 or 4: Do not administer until resolution to Grade ≤2

Nodular regenerative hyperplasia

  • All grades: Permanently discontinue

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): Dose adjustment not necessary (based on population pharmacokinetics)
  • Severe (CrCl <30 mL/min): No dosage adjustment can be recommended owing to limited data

Hepatic impairment

  • Mild or moderate: No adjustment to starting dose required; monitor closely patients with hepatic impairment owing to risk of hepatotoxicity associated with therapy
  • Severe: Not studied

Dosing Considerations

Do not substitute ado-trastuzumab emtansine (Kadcyla) for or with trastuzumab (Herceptin)

Patient Selection

  • Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens
  • Perform assessment of HER2 protein overexpression and/or HER2 gene amplification using FDA-approved tests specific for breast cancers by laboratories with demonstrated proficiency
  • Information on the FDA-approved tests for detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics

Safety and efficacy not established

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Interactions

Interaction Checker

and ado-trastuzumab emtansine

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            Contraindicated (0)

              Serious - Use Alternative (33)

              • abametapir

                abametapir will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • atazanavir

                atazanavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • baricitinib

                baricitinib, ado-trastuzumab emtansine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Baricitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressives.

              • chloramphenicol

                chloramphenicol will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • clarithromycin

                clarithromycin increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • cobicistat

                cobicistat will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • conivaptan

                conivaptan increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • darunavir

                darunavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • deferiprone

                deferiprone, ado-trastuzumab emtansine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • fexinidazole

                fexinidazole will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • fosamprenavir

                fosamprenavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • idelalisib

                idelalisib will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • imatinib

                imatinib increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • indinavir

                indinavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • isoniazid

                isoniazid increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • itraconazole

                itraconazole increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider an alternate medication with no or minimal potential to inhibit CYP3A4. If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying ado-trastuzumab until the strong CYP3A4 inhibitors have cleared from the circulation (~3 elimination half-lives of the inhibitors) when possible. If a strong CYP3A4 inhibitor is coadministered and ado-trastuzumab cannot be delayed, closely monitor for adverse reactions.

              • ivosidenib

                ivosidenib will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

              • ketoconazole

                ketoconazole increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • lonafarnib

                lonafarnib will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • lopinavir

                lopinavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • nefazodone

                nefazodone increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • nelfinavir

                nelfinavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • nicardipine

                nicardipine increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • palifermin

                palifermin increases toxicity of ado-trastuzumab emtansine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, 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.

              • posaconazole

                posaconazole increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • quinidine

                quinidine increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • ritonavir

                ritonavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • saquinavir

                saquinavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • tipranavir

                tipranavir increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • voriconazole

                voriconazole increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. DM1, the cytotoxic component, is metabolized mainly by CYP3A4; strong CYP3A4 inhibitors may increase DM1 exposure and toxicity.

              • voxelotor

                voxelotor will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (25)

              • belzutifan

                belzutifan will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

              • cenobamate

                cenobamate will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • cholera vaccine

                ado-trastuzumab emtansine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dabrafenib

                dabrafenib will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • dengue vaccine

                ado-trastuzumab emtansine 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.

              • dichlorphenamide

                dichlorphenamide and ado-trastuzumab emtansine both decrease serum potassium. Use Caution/Monitor.

              • duvelisib

                duvelisib will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

              • elagolix

                elagolix will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • encorafenib

                encorafenib, ado-trastuzumab emtansine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

              • fedratinib

                fedratinib will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • ifosfamide

                ifosfamide, ado-trastuzumab emtansine. Other (see comment). Use Caution/Monitor. Comment: Risk of developing cardiotoxic effects increase in patients with prior or concomitant treatment with other cardiotoxic agents.

              • iloperidone

                iloperidone increases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

              • istradefylline

                istradefylline will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • mifepristone

                mifepristone will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If coadministration necessary, closely monitor patients for ado-trastuzumab emtansine-related adverse reactions

              • mitotane

                mitotane decreases levels of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • ofatumumab SC

                ofatumumab SC, ado-trastuzumab emtansine. 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.

              • ponesimod

                ponesimod and ado-trastuzumab emtansine 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.

              • ribociclib

                ribociclib will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rucaparib

                rucaparib will increase the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • siponimod

                siponimod and ado-trastuzumab emtansine 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.

              • stiripentol

                stiripentol, ado-trastuzumab emtansine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • tazemetostat

                tazemetostat will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of ado-trastuzumab emtansine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • trastuzumab

                trastuzumab, ado-trastuzumab emtansine. 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, ado-trastuzumab emtansine. 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. .

              Minor (0)

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                Adverse Effects

                All grades of severity are listed unless otherwise indicated

                >10% (All Grades for MBC)

                Nausea (40%)

                Fatigue (36%)

                Musculoskeletal pain (36%)

                Hemorrhage (32%)

                Thrombocytopenia (31%)

                AST/ALT increased (29%)

                Constipation (27%)

                Headache (28%)

                Diarrhea (24%)

                Epistaxis (23%)

                Peripheral neuropathy (21%)

                Vomiting (19%)

                Abdominal pain (19%)

                Pyrexia (19%)

                Arthralgia (19%)

                Asthenia (18%)

                Cough (18%)

                Dry mouth (17%)

                Myalgia (14%)

                Anemia (14%)

                Stomatitis (14%)

                Insomnia (12%)

                Dyspnea (12%)

                Rash (12%)

                >10% (All Grades for EBC)

                Fatigue (50%)

                Nausea (42%)

                AST/ALT increased (32%)

                Musculoskeletal pain (30%)

                Thrombocytopenia (29%)

                Hemorrhage (29%)

                Headache (28%)

                Peripheral neuropathy (28%)

                Arthralgia (26%)

                Epistaxis (22%)

                Constipation (17%)

                Myalgia (15%)

                Stomatitis (15%)

                Vomiting (15%)

                Dry Mouth (14%)

                Cough (14%)

                Insomnia (14%)

                Diarrhea (12%)

                Abdominal pain (11%)

                >10% (MBC [Grade 3 or 4])

                Thrombocytopenia (15%)

                1-10% (All Grades)

                MBC

                • Hypokalemia (10%)
                • Dizziness (10%)

                EBC

                • Anemia (10%)
                • Pyrexia (10%)
                • Dizziness (10%)
                • Urinary tract infection (10%)

                1-10% (Grade 3 or 4)

                MBC

                • AST/ALT increased (8%)
                • Anemia (4.1%)
                • Hypokalemia (2.7%)
                • Fatigue (2.5%)
                • Peripheral neuropathy (2.2%)
                • Musculoskeletal pain (1.8%)
                • Hemorrhage (1.8%)
                • Diarrhea (1.6%)

                EBC

                • Thrombocytopenia (6%)
                • Peripheral neuropathy (1.6%)
                • AST/ALT increased (1.5%)

                <1% (Grade 3 or 4)

                Nausea/vomiting (0.8%)

                Headache (0.8%)

                Dyspnea (0.8%)

                Arthralgia/myalgia (0.6%)

                Nausea (0.5%)

                Constipation (0.4%)

                Asthenia (0.4%)

                Dizziness (0.4%)

                Insomnia (0.4%)

                Dry mouth (0.4%)

                Stomatitis (0.2%)

                Pyrexia (0.2%)

                Epistaxis (0.2%)

                Cough (0.2%)

                Postmarketing Reports

                Tumor lysis syndrome (TLS) reported; significant tumor burden (eg, bulky metastases) increases risk

                CHF and > 10% reduction in LVEF in patients with baseline LVEF of 40-49%

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                Warnings

                Black Box Warnings

                Hepatotoxicity

                • Serious hepatoxicity reported, including liver failure and death
                • Monitor serum transaminases and bilirubin before initiating and prior to each dose
                • Reduce dose or discontinue as appropriate with elevated transaminases or total bilirubin (see Dosage modifications)

                Cardiac toxicity

                • May decrease LVEF
                • Evaluate LVEF in all patients before and during treatment
                • Withhold treatment for clinically significant decrease in LVEF (see Dosage Modifications)

                Embryofetal toxicity

                • Can result in embryofetal death or birth defects
                • Postmarketing reports of oligohydramnios, some associated with fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death DM1, the cytotoxic component, can be expected to cause embryofetal toxicity based on its mechanism of action
                • Advise patient of risk and the need for effective contraception
                • Verify pregnancy status prior to initiation

                Contraindications

                None

                Cautions

                Hepatotoxicity, predominantly in the form of asymptomatic, transient increases in the concentrations of serum transaminases, reported (see Black Box Warnings and Dosage Modifications)

                Cases of nodular regenerative hyperplasia of the liver reported; upon diagnosis of nodular regenerative hyperplasia of the liver, treatment must be permanently discontinued

                CHF and > 10% reduction in LVEF in patients with HER2-positive metastatic breast cancer with a baseline LVEF of 40-49% that received treatment reported (see Black Box Warnings and Dosage Modifications)

                Discontinue treatment permanently if patient diagnosed with nodular regenerative hyperplasia

                Known to cause fetal harm and death (see Black Box Warnings)

                Pulmonary toxicity may occur; cases of interstitial lung disease, including pneumonitis reported, permanently discontinue drug (see Dosage Modifications)

                For patients with radiation pneumonitis in the adjuvant setting, therapy should be permanently discontinued for grade greater than or equal to 3 or for grade 2 not responding to standard treatment

                Patients with dyspnea at rest due to complications of advanced malignancy, co-morbidities, and receiving concurrent pulmonary radiation therapy may be at increased risk of pulmonary toxicity

                Infusion-related reactions (IRRs) and/or hypersensitivity may occur; temporarily interrupt infusion for severe IRRs and permanently discontinue if life-threatening IRR occurs

                Thrombocytopenia or decreased platelet counts reported (see Dosage Modifications)

                Hemorrhagic events (including CNS, respiratory, and GI hemorrhage) have been reported; although, in some cases patients were also receiving anticoagulation therapy, antiplatelet therapy, or had thrombocytopenia, in others there were no known additional risk factors; use caution with these agents and consider additional monitoring when concomitant use is medically necessary

                Peripheral neuropathy may occur (see Dosage Modifications)

                Extravasation observed during clinical trials; carefully monitor infusion site during infusion and inform patient to report any tenderness/redness

                Cases of possible tumor lysis syndrome (TLS) reported in patients treated; patients with significant tumor burden (eg, bulky metastases) may be at a higher risk; patients could present with hyperuricemia, hyperphosphatemia, and acute renal failure which may represent possible TLS; providers should consider additional monitoring and/or treatment as clinically indicated

                Drug interactions overview

                • DM1, the cytotoxic component of ado-trastuzumab emtansine, is a CYP3A4 substrate
                • Avoid concomitant use of strong CYP3A4 inhibitors owing to the potential for an increase in DM1 exposure and toxicity; consider an alternative with no or minimal potential to inhibit CYP3A4
                • If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying ado-trastuzumab emtansine until strong CYP3A4 inhibitors have cleared from the circulation (~3 elimination half-lives of the inhibitors) when possible
                • If a strong CYP3A4 inhibitor is coadministered and ado-trastuzumab emtansine cannot be delayed, closely monitor patient for adverse reactions
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                Pregnancy & Lactation

                Pregnancy

                Therapy can cause fetal harm when administered to a pregnant woman

                No data available on use in pregnant women; cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death were observed in postmarketing setting in patients treated with trastuzumab, the antibody component

                Based on mechanism of action, the DM1 component can also cause embryofetal harm when administered to a pregnant woman

                Advise patient of potential risks to a fetus; there are clinical considerations if drug is used in a pregnant woman, or if a patient becomes pregnant within 7 months following last dose

                Pregnancy pharmacovigilance program

                • If administered during pregnancy, or if a patient becomes pregnant while receiving therapy or within 7 months following the last dose, immediately report ado-trastuzumab emtansine exposure to Genentech at 1-888-835-2555

                Reproductive potential

                • Verify pregnancy status of females of reproductive potential prior to initiation of therapy

                Contraception

                • Females: Drug can cause embryofetal harm when administered during pregnancy; advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose
                • Males: Because of potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 4 months following the last dose

                Infertility

                • Based on results from animal toxicity studies, therapy may impair fertility in females and males of reproductive potential; not known if effects are reversible

                Lactation

                There is no information regarding presence of ado-trastuzumab emtansine in human milk, effects on breastfed infant, or on milk production; DM1, the cytotoxic component of the drug, may cause serious adverse reactions in breastfed infants based on its mechanism of action; advise women not to breastfeed during treatment and for 7 months following last dose of the drug

                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

                HER2-targeted antibody-drug conjugate (ADC) which contains the humanized anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitory drug DM1 (a maytansine derivative)

                Upon binding to sub-domain IV of the HER2 receptor, ado-trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites

                Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest and apoptotic cell death

                In addition, in vitro studies have shown that similar to trastuzumab, ado-trastuzumab emtansine inhibits HER2 receptor signaling, mediates antibody-dependent cell-mediated cytotoxicity and inhibits shedding of the HER2 extracellular domain in human breast cancer cells that overexpress HER2

                Absorption

                Peak plasma time: Near end of infusion

                Peak plasma concentration: 83.4 mcg/mL (ADC); 4.61 ng/mL (DM1)

                Distribution

                Protein bound: 93% (DM1)

                Vd: 3.13 L (ADC)

                DM1 is a P-gp substrate (in vitro)

                Metabolism

                DM1 metabolized by mainly by CYP3A4 and to a lesser degree by CYP3A5

                Elimination

                Half-life: 4 days (ADC)

                Total body clearance: 0.68 L/day (ADC)

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                Administration

                IV Incompatibilities

                Dextrose 5%

                Do not mix or administer as an infusion with other medicinal products

                IV Compatibilities

                0.9% NaCl

                IV Preparation

                Use aseptic technique and procedures for antineoplastic drug preparation

                Reconstitution

                • Reconstitute vial by slowly injecting with sterile water for injection (SWI)
                • Gently swirl vial until completely dissolved; do not shake
                • Inspect reconstituted solution for particulates and discoloration (colorless to pale brown); do not use if particulates are visible or solution is cloudy or discolored
                • 100-mg vial: Reconstitute with 5 mL SWI
                • 160-mg vial: Reconstitute with 8 mL SWI
                • Resulting concentration is 20mg/mL

                Dilution

                • Withdraw calculated amount from vial and add to a 0.9% NaCl 250-mL infusion bag
                • Gently invert bag to mix solution in order to avoid foaming

                IV Administration

                Administer as IV infusion only with a 0.22 micron in-line nonprotein adsorptive polyethersulfone (PES) filter

                Do NOT give as IV push or bolus

                Do not mix or infuse with other medicinal products

                Do not substitute trastuzumab for or with ado-trastuzumab emtansine

                Closely monitor IV infusion site for possible SC infiltration

                First infusion: Administer over 90 minutes; observe for fever, chills, or other infusion-related reactions (IRRs) during infusion and for at least 90 minutes afterwards

                Subsequent infusions: Administer over 30 minutes if prior infusion well tolerated; observe for IRRs during infusion and for at least 30 minutes afterwards

                Slow or interrupt dose if IRR occurs; permanently discontinue for life-threatening related reactions

                Missed dose

                • If a planned dose is delayed or missed, administer as soon as possible; do not wait until the next planned cycle
                • Adjust dosing schedule to maintain a 3-week interval between doses
                • Administer infusion at dose and rate the patient tolerated in the most recent infusion

                Storage

                Unused vials: Refrigerate at 2-8ºC (36-46°F)

                Reconstituted vials or diluted solutions

                • Refrigerate at 2-8ºC (36-46°F)
                • Discard after 24 hr
                • Do NOT freeze
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Kadcyla intravenous
                -
                100 mg vial
                Kadcyla intravenous
                -
                160 mg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                ado-trastuzumab emtansine intravenous

                TRASTUZUMAB EMTANSINE - INJECTION

                (tras-TOOZ-ue-mab em-TAN-seen)

                COMMON BRAND NAME(S): Kadcyla

                WARNING: Trastuzumab emtansine has rarely caused very serious (possibly fatal) liver disease. Get medical help right away if you develop symptoms of liver disease, including persistent nausea, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.Trastuzumab emtansine may lead to serious heart problems, including heart failure. Past use of certain other anti-cancer drugs (including anthracyclines such as doxorubicin) may increase your risk of heart problems. Tell your doctor right away if you have any symptoms of heart failure, including shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.Trastuzumab emtansine can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor.

                USES: Trastuzumab emtansine is used to treat certain types of breast cancer. This medication is used to treat tumors that produce more than the normal amount of a certain substance called HER2 protein.This medication is called a monoclonal antibody and microtubule inhibitor conjugate. Trastuzumab emtansine works by attaching to the HER2 cancer cells and blocking them from dividing and growing. It may also destroy the cancer cells or signal the body (immune system) to destroy the cancer cells.This monograph is about the following trastuzumab emtansine products: trastuzumab emtansine, ado-trastuzumab emtansine.

                HOW TO USE: This medication is given by slow injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 3 weeks. Your first infusion will be given over at least 90 minutes.The dosage, the speed of your injection, and the length of time you receive trastuzumab emtansine is based on your body weight, medical condition, and response to treatment.To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.Your doctor may prescribe other medications (such as acetaminophen, diphenhydramine) for you to take before the start of your treatment to help prevent serious side effects.

                SIDE EFFECTS: See also Warning section.Diarrhea, redness/irritation at the injection site, dizziness, muscle/joint/back pain, stomach/abdominal pain, constipation, trouble sleeping, nausea, vomiting, mouth sores, dry mouth, changes in taste, 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 persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: bone pain, increased coughing, swelling of the hands/ankles/feet, unusual tiredness, severe headache, tingling/numbness (such as in the hands, feet, leg), mental/mood changes, fast/pounding heartbeat, muscle cramps, easy bruising/bleeding.This drug has caused very serious (rarely fatal) bleeding. Get medical help right away if you develop symptoms of very serious bleeding, including: weakness on one side of the body, trouble speaking, vision changes, confusion, severe stomach/abdominal pain, trouble breathing, vomit that is bloody or looks like coffee grounds, black/tarry stool.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).This medication can sometimes cause a serious infusion reaction with serious lung problems. Immediately tell your doctor of the following side effects that occur while this drug is being given or within 24 hours after your treatment is finished, such as chills, fever, flushing, wheezing, shortness of breath, nausea, headache, dizziness, fainting, rash, and weakness.Trastuzumab emtansine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.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, including: 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: See also Warning section.Before using trastuzumab emtansine, tell your doctor or pharmacist if you are allergic to it; or to any trastuzumab deruxtecan, trastuzumab emtansine, trastuzumab, or trastuzumab-hyaluronidase products; 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: previous cancer treatments (including radiation therapy to the chest), current infection, heart disease, high blood pressure, lung problems, previous severe reaction to monoclonal antibody treatment, liver disease (including a rare liver condition called nodular regenerative hyperplasia).Trastuzumab emtansine can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. 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.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug, especially heart problems (such as heart failure).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using trastuzumab emtansine. Trastuzumab emtansine may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 7 months after stopping treatment. Men should ask about reliable forms of birth control while using this medication and for 4 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 7 months after the last dose. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: See also Warning section.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 (including 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.If you will be using an anthracycline (such as doxorubicin) after stopping trastuzumab emtansine treatment, if possible, wait at least 7 months.Other medications can affect the removal of trastuzumab emtansine from your body, which may affect how trastuzumab emtansine works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, HIV protease inhibitors (such as atazanavir, ritonavir), nefazodone, telithromycin, among others.Trastuzumab emtansine is very similar to trastuzumab, trastuzumab deruxtecan, and trastuzumab-hyaluronidase. Do not use a trastuzumab, trastuzumab deruxtecan, or trastuzumab-hyaluronidase product while using a trastuzumab emtansine product.

                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 heart exams, platelet counts, liver function, bilirubin level) should be done before you start using this medication and while you are using it. A pregnancy test should also be done before starting treatment. Keep all medical and lab appointments. Consult your doctor for more details.

                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.

                STORAGE: Not applicable. This medication is given in a clinic or hospital and will not be stored at home.

                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 September 2021. Copyright(c) 2021 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.