pemetrexed (Rx)

Brand and Other Names:Alimta, Pemfexy
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 100mg/vial (Alimta)
  • 500mg/vial (Alimta)

injectable solution

  • 500mg/vial (Pemfexy)

Mesothelioma

Indicated as initial treatment, in combination with cisplatin, for malignant pleural mesothelioma in patients whose disease is unresectable or are not candidates for curative surgery

In combination with cisplatin: Pemetrexed 500 mg/m2 IV on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity  

Nonsquamous Non-Small Cell Lung Carcinoma

Combination with pembrolizumab and platinum chemotherapy

  • Alimta only
  • Indicated for initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations
  • In combination with pembrolizumab and platinum chemotherapy: Pemetrexed 500 mg/m2 IV on Day 1 of each 21-day cycle for 4 cycles  
  • Following completion of platinum-based therapy, continue pemetrexed with or without pembrolizumab until disease progression or unacceptable toxicity

Combination with cisplatin

  • Alimta, Pemfexy
  • Indicated for initial treatment of patients with locally advanced or metastatic nonsquamous NSCLC
  • In combination with cisplatin: Pemetrexed 500 mg/m2 IV on Day 1 of each 21-day cycle for up to 6 cycles in the absence of disease progression or unacceptable toxicity  

Single agent

  • Alimta, Pemfexy
  • Indicated as a single agent for treatment of patients with recurrent, metastatic nonsquamous NSCLC after prior chemotherapy
  • Also, indicated as a single agent for maintenance treatment of patients with locally advanced or metastatic, nonsquamous NSCLC whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy
  • 500 mg/m2 IV on Day 1 of each 21-day cycle  
  • Continue until disease progression or unacceptable toxicity

Dosage Modifications

Modification of ibuprofen dosing in patients on pemetrexed with CrCl (45-79 mL/min)

  • Avoid ibuprofen for 2 days before, day of, and 2 days following administration of therapy
  • Closely monitor for myelosuppression, renal toxicity, and gastrointestinal toxicity, if concomitant use of ibuprofen cannot be avoided

Delay initiation of the next cycle of pemetrexed until:

  • Recovery of nonhematologic toxicity Grade ≤2; AND
  • Absolute neutrophil count (ANC) ≥1500 cells/mm3 AND
  • Platelet count ≥100,000 cells/mm3

Adjust to 75% of previous dose

  • ANC <500/mm3 and platelets ≥50,000 cells/mm3
  • Platelet count <50,000 cells/mm3 without bleeding
  • Any Grade 3 or 4 nonhematologic toxicities EXCEPT mucositis or neurologic toxicity
  • Diarrhea requiring hospitalization

Adjust to 50% of previous dose

  • Platelet count <50,000 cells/mm3 with bleeding
  • Grade 3 or 4 mucositis

Discontinue

  • Recurrent Grade 3 or 4 myelosuppression after 2 dose reductions
  • Permanently discontinue
    • Grade 3 or 4 neurologic toxicity
    • Recurrent Grade 3 or 4 nonhematologic toxicity after 2 dose reductions
    • Severe and life-threatening skin toxicity
    • Interstitial pneumonitis

Renal impairment

  • CrCl (calculated by Cockcroft-Gault equation) ≥45 mL/min: No dosage adjustment necessary
  • CrCl <45 mL/min: No recommended dose; do not administer

Hepatic impairment

  • Not studied; no effect of elevated AST, ALT, or total bilirubin on the pharmacokinetics of pemetrexed was observed in clinical studies

Dosing Considerations

Limitation of use: Not indicated for treatment of patients with squamous cell NSCLC

Obtain complete blood cell (CBC) count on Days 1, 8, and 15 of each cycle; assess CrCl prior to each cycle

Safety and efficacy not established

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Interactions

Interaction Checker

and pemetrexed

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (32)

              • aspirin

                aspirin increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • aspirin rectal

                aspirin rectal increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Especially in pts. w/mild moderate renal insufficiency. D/C NSAIDs 2 5 d before and 2 d after pemetrexed administration.

              • aspirin/citric acid/sodium bicarbonate

                aspirin/citric acid/sodium bicarbonate increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • bacitracin

                pemetrexed and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs

              • celecoxib

                celecoxib increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • choline magnesium trisalicylate

                choline magnesium trisalicylate increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Especially in pts. w/mild moderate renal insufficiency. D/C NSAIDs 2 5 d before and 2 d after pemetrexed administration.

              • deferiprone

                deferiprone, pemetrexed. 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.

              • diclofenac

                diclofenac increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • diflunisal

                diflunisal increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • etodolac

                etodolac increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • fenoprofen

                fenoprofen increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • flurbiprofen

                flurbiprofen increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • ibuprofen

                ibuprofen increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Especially in pts. w/mild moderate renal insufficiency. D/C NSAIDs 2 5 d before and 2 d after pemetrexed administration.

              • ibuprofen IV

                ibuprofen IV increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Especially in pts. w/mild moderate renal insufficiency. D/C NSAIDs 2 5 d before and 2 d after pemetrexed administration.

              • indomethacin

                indomethacin increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug.

              • ketoprofen

                ketoprofen increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • ketorolac

                ketorolac increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • ketorolac intranasal

                ketorolac intranasal increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Especially in pts. w/mild moderate renal insufficiency. D/C NSAIDs 2 5 d before and 2 d after pemetrexed administration.

              • meclofenamate

                meclofenamate increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • mefenamic acid

                mefenamic acid increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • meloxicam

                meloxicam increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • nabumetone

                nabumetone increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • naproxen

                naproxen increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • oxaprozin

                oxaprozin increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • palifermin

                palifermin increases toxicity of pemetrexed 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.

              • piroxicam

                piroxicam increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • salicylates (non-asa)

                salicylates (non-asa) increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • salsalate

                salsalate increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • sulfasalazine

                sulfasalazine increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • sulindac

                sulindac increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              • tofacitinib

                pemetrexed, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tolmetin

                tolmetin increases levels of pemetrexed by unspecified interaction mechanism. Avoid or Use Alternate Drug. Interrupt dosing in all patients taking NSAIDs with long elimination half-lives for at least 5d before, the day of, and 2d following pemetrexed administration. If coadministration of an NSAID is necessary, closely monitor patients for toxicity, especially myelosuppression, renal toxicity, and GI toxicity.

              Monitor Closely (14)

              • cholera vaccine

                pemetrexed 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.

              • dengue vaccine

                pemetrexed 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

                pemetrexed, 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.

              • fingolimod

                pemetrexed 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. .

              • glucarpidase

                glucarpidase will decrease the level or effect of pemetrexed by increasing metabolism. Modify Therapy/Monitor Closely. Leucorvorin, reduced folates, and folate antimetabolites are substrates for glucarpidase (hydrolyzes glutamate residue from folic acid and antifolates)

              • influenza A (H5N1) vaccine

                pemetrexed decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                pemetrexed decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • ofatumumab SC

                ofatumumab SC, pemetrexed. 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.

              • peramivir

                pemetrexed increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.

              • siponimod

                siponimod and pemetrexed 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

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

              • tenofovir DF

                pemetrexed, tenofovir DF. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

                pemetrexed, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, pemetrexed. 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, pemetrexed. 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 (1)

              • entecavir

                pemetrexed, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

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              Adverse Effects

              >10% (All Grades)

              Nausea (31-82%)

              Vomiting (16-57%)

              Neutropenia (11-56%)

              Fatigue (34-48%)

              Anemia (19-26%)

              Thrombocytopenia (8-23%)

              Stomatitis/pharyngitis (15-23%)

              Anorexia (20-22%)

              Diarrhea (13-17%)

              Rash (14-16%)

              Decreased CrCl (16%)

              Constipation (6-12%)

              Alopecia (11%)

              Elevated creatinine (11%)

              >10% (Grade 3 or 4)

              Neutropenia (5-23%)

              Nausea (12%)

              Vomiting (2-11%)

              1-10% (All Grades)

              Sensory neuropathy (10%)

              Taste disturbance (8%)

              Increased ALT (1-8%)

              Fever (8%)

              Pruritus (7%)

              Increased AST (1-7%)

              Dehydration (7%)

              Alopecia (6%)

              Dyspepsia (5%)

              Conjunctivitis (5%)

              Abdominal pain (1-5%)

              Allergic reaction/hypersensitivity (1-5%)

              Febrile neutropenia (1-5%)

              Infection (1-5%)

              Urticaria (1-5%)

              Chest pain (1-5%)

              Erythema multiforme (1-5%)

              Renal failure (1-5%)

              Motor or sensory neuropathy (1-5%)

              Dyspepsia (1%)

              1-10% (Grade 3 or 4)

              Fatigue (5-10%)

              Thrombocytopenia (2-5%)

              Anemia (4%)

              Dehydration (4%)

              Diarrhea (4%)

              Nausea (3%)

              Stomatitis/pharyngitis (1-3%)

              Increased ALT (2%)

              Anorexia (2%)

              Rash (1%)

              Alopecia (1%)

              Constipation (1%)

              Anorexia (1%)

              Increased AST (1%)

              Decreased CrCl (1%)

              <1%

              Supraventricular arrhythmias

              Renal failure

              Motor neuropathy

              Postmarketing Reports

              Gastrointestinal: Colitis, pancreatitis

              Blood and lymphatic system: Immune-mediated hemolytic anemia

              General: Edema

              Injury, poisoning, and procedural complications: Radiation recall

              Respiratory: Interstitial pneumonitis

              Skin: Serious and fatal bullous skin conditions, Stevens-Johnson syndrome, and toxic epidermal necrolysis

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              Warnings

              Contraindications

              History of severe hypersensitivity reaction to pemetrexed

              Cautions

              Treatment can cause severe, and sometimes fatal, renal toxicity; determine creatinine clearance before each dose and periodically monitor renal function during treatment with drug; withhold therapy in patients with a creatinine clearance of <45 mL/minute

              Serious and sometimes fatal, bullous, blistering and exfoliative skin toxicity, including cases suggestive of Stevens-Johnson Syndrome/Toxic epidermal necrolysis can occur; permanently discontinue drug for severe and life-threatening bullous, blistering or exfoliating skin toxicity

              Serious interstitial pneumonitis, including fatal cases, can occur with treatment; withhold drug for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, or fever pending diagnostic evaluation; if pneumonitis is confirmed, permanently discontinue therapy

              Radiation recall can occur in patients who have received radiation weeks to years previously; monitor patients for inflammation or blistering in areas of previous radiation treatment; permanently discontinue therapy for signs of radiation recall

              Based on findings from animal studies and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; avoid pregnancy (see Pregnancy)

              Myelosuppression

              • Therapy can cause severe myelosuppression resulting in a requirement for transfusions and which may lead to neutropenic infection; risk of myelosuppression is increased in patients who do not receive vitamin supplementation
              • Initiate supplementation with oral folic acid and intramuscular vitamin B12 prior to first dose of treatment; continue vitamin supplementation during treatment and for 21 days after last dose to reduce severity of hematologic and gastrointestinal toxicity of treatment;
              • Obtain a complete blood count at beginning of each cycle; do not administer treatment until the ANC is at least 1500 cells/mm3 and platelet count is at least 100,000 cells/mm3
              • Permanently reduce dose in patients with an ANC of less than 500 cells/mm3 or platelet count <50,000 cells/mm3 in previous cycles

              Drug interactions overview

              • Exposure to drug is increased in patients with mild to moderate renal impairment who take concomitant ibuprofen, increasing risks of adverse reactions; in patients with creatinine clearances between 45 mL/min and 79 mL/min, avoid administration of ibuprofen for 2 days before, the day of, and 2 days following administration of drug; if concomitant ibuprofen use cannot be avoided, monitor patients more frequently for adverse reactions, including myelosuppression, renal, and gastrointestinal toxicity
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              Pregnancy & Lactation

              Pregnancy

              Based on findings from animal studies and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman

              There are no available data in pregnant women; in animal reproduction studies, IV administration of pemetrexed to pregnant mice during organogenesis was teratogenic, resulting in developmental delays and malformations at doses lower than recommended human dose of 500 mg/m2; advise pregnant women of the potential risk to a fetus

              Contraception

              • Females of reproductive potential: Use effective contraception during treatment for at least 6 months after final dose
              • Males with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after final dose

              Infertility

              • Therapy may impair fertility in males of reproductive potential; it is not known whether these effects on fertility are reversible

              Lactation

              There is no information regarding presence of drug or its metabolites in human milk, effects on breastfed infant, or on milk production; because of potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment and for 1 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

              Antifolate antineoplastic agent

              Disrupts folate-dependent metabolic processes essential for cell replication

              Distribution

              Vd (ss): 16.1 L

              Protein bound: 81%

              Metabolism

              Metabolites: Polyglutamate forms

              Enzymes inhibited

              • Thymidylate synthase
              • Dihydrofolate reductase
              • Glycinamide ribonucleotide formyltransferase
              • All folate-dependent enzymes involved in de novo biosynthesis of thymidine and purine nucleotides

              Elimination

              Total body clearance: 91.8 mL/min

              Half-life: 3.5 hr

              Excretion: Urine (70-90%)

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              Administration

              IV Incompatibilities

              Alimta

              • Do not use calcium-containing solutions for reconstitution, including Lactated Ringer or Ringer solution

              Pemfexy

              • Do not use other diluents, such as Lactated Ringer or Ringer solution

              IV Compatibilities

              Alimta: 0.9% NaCl

              Pemfexy: Dextrose 5%; compatible with polyolefin infusion bags with polyvinyl chloride (PVC) ports

              IV Preparation

              Pemetrexed a cytotoxic drug; follow applicable special handling and disposal procedures

              Reconstitution

              • Alimta: Reconstitute with 0.9% NaCl (preservative-free); add 4.2 mL to 100-mg vial and 20 mL to the 500-mg vial; final vial concentration is 25 mg/mL

              Further dilution

              • Gently swirl until completely dissolved; resulting solution is clear and ranges in color from colorless to yellow/green-yellow without adversely affecting quality
              • Visually inspect particulate matter and discoloration prior to further dilution; if particulate matter is observed, discard vial
              • Withdraw calculated dose from vial(s) and discard vial with any unused portion
              • Further dilute reconstituted vial with 0.9% NaCl (Alimta) or Dextrose 5% (Pemfexy) to achieve a total volume of 100 mL for IV infusion

              Premedication Regimen

              Folic acid: 400-1000 mcg PO qDay beginning 7 days before first pemetrexed dose; continue until 21 days after last dose

              Vitamin B-12: 1 mg IM beginning 1 week before first pemetrexed dose and repeat every 3 cycles thereafter; subsequent doses may be administered on the same day as pemetrexed

              Do not substitute PO vitamin B-12 for IM (see Cautions)

              Dexamethasone: 4 mg PO BID for 3 consecutive days starting the day before pemetrexed administration

              IV Administration

              Infuse over 10 min

              For combination therapy: Administer after pembrolizumab and prior to carboplatin or cisplatin

              Storage

              Alimta

              • Unused vials: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
              • Reconstituted vials: Refrigerate at 2-8°C (36-46°F) for no longer than 24 hr from the time of reconstitution; discard vial after 24 hr
              • Diluted infusion: Refrigerate at 2-8°C (36-46°F) for no more than 24 hr from the time of reconstitution; discard after 24 hr

              Pemfexy

              • Unused vials: Refrigerate at 2-8°C (36-46°F)
              • Reconstituted vials: Refrigerate at 2-8°C (36-46°F) or ambient room temperature for no longer than 48 hr from the time of reconstitution; discard vial after 48 hr
              • Diluted infusion: Refrigerate at 2-8°C (36-46°F) for no more than 48 hr from the time of reconstitution; discard after 48 hr
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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Alimta intravenous
              -
              100 mg vial
              Alimta intravenous
              -
              500 mg vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              pemetrexed intravenous

              PEMETREXED - INJECTION

              (PEM-e-TREX-ed)

              COMMON BRAND NAME(S): Alimta

              USES: Pemetrexed is used to treat certain types of cancer (such as lung cancer, mesothelioma). It is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.

              HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start receiving pemetrexed and each time you receive a dose. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein by a healthcare professional. It is given over 10 minutes as directed by your doctor, usually once every 3 weeks. The dosage is based on your medical condition, body size, and response to treatment. To lower your chance of having a skin reaction while using pemetrexed, your doctor will prescribe a corticosteroid medicine (such as dexamethasone) to take for a short period around the time of each treatment. Consult your doctor or pharmacist for more details.To lower your chance of other side effects, it is very important that you take folic acid vitamins and receive vitamin B12 shots before and during treatment with pemetrexed. Folic acid vitamins are available over-the-counter without a prescription, and folic acid can be found in many multivitamin products. Make sure your vitamin contains between 400 to 1000 micrograms (0.4 to 1 milligram) of folic acid. Take folic acid daily for at least 5 out of 7 days before your first dose of pemetrexed, during treatment, and for 3 weeks after your last dose of pemetrexed. If you need help choosing a folic acid vitamin, ask your doctor or pharmacist. Your doctor will give you a vitamin B12 shot into the muscle, usually 1 week before your first dose of pemetrexed and then once every 9 weeks during your treatment. Do not substitute vitamin B12 taken by mouth for the vitamin B12 shots. Consult your doctor or pharmacist for more details.

              SIDE EFFECTS: Nausea, vomiting, loss of appetite, diarrhea, stomach upset, changes in taste, constipation, mouth sores, and tiredness may occur. Nausea, vomiting, and diarrhea can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea, vomiting, and diarrhea. Eating several small meals, not eating before treatment, or limiting activity may help lessen nausea and vomiting. 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, including: numbness/tingling skin, swelling ankles/feet/hands, signs of kidney problems (such as change in the amount of urine), signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine).This medication may decrease bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.Get medical help right away if you have any very serious side effects, including: blisters or sores, signs of lung problems (such as new or worsening shortness of breath, cough).Pemetrexed may cause a serious skin reaction that looks like a severe sunburn (radiation recall) on any area that has been treated with radiation weeks to years before. Get medical help right away if you have skin redness, pain, tenderness, swelling, peeling, or blisters.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.Pemetrexed can commonly cause a rash that is usually not serious and that can be prevented by taking corticosteroid medication (see How to Use section). However, you may not be able to tell the rash apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.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 using pemetrexed, tell your doctor or pharmacist if you are allergic to it; 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: kidney disease, liver disease, radiation treatment.Pemetrexed 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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication can affect fertility in males. Ask your doctor for more details.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using pemetrexed. Pemetrexed may harm an unborn baby. Female patients should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Male patients with female partners should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner become 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 while using this drug and for 1 week after stopping treatment 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 (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.

              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: Lab and/or medical tests (such as complete blood count, liver/kidney function) should be done while you are taking this medication. 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 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 August 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

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              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.