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pemetrexed (Rx)Brand and Other Names:Alimta

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 500mg/vial
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Malignant Pleural Mesothelioma

Indicated for mesothelioma in combination with cisplatin in patients whose disease is unresectable or are not candidates for curative surgery

Combination use with cisplatin: 500 mg/m² IV over 10 minutes on Day 1 of each 21-day cycle; administer cisplatin (75 mg/m² IV over 2 hr) 30 minutes after end of premetrexed infusion 

Nonsquamous Non-Small Cell Lung Carcinoma

Indications

  • Initial treatment: In combination with cisplatin for initial treatment with locally advanced or metastatic nonsquamous NSCLC
  • Maintenance: Locally advanced or metastatic nonsquamous NSCLC in patients whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy
  • After prior chemotherapy: As a single agent of locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy

Single-agent use: 500 mg/m² IV infusion over 10 minutes on Day 1 of each 21-day cycle  

Combination use with cisplatin: 500 mg/m² IV over 10 minutes on Day 1 of each 21-day cycle; administer cisplatin (75 mg/m² IV over 2 hr) 30 minutes after end of premetrexed infusion

Premedication Regimen

Folic acid: 400-1000 mcg PO qDay beginning 7 days before first pemetrexed dose; continue during the full course of therapy and for 21 days after the last dose

Vitamin B12: 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 B12 for IM (see Cautions)

Dexamethasone: 4 mg PO BID on the day before, day of, and day after pemetrexed administration treatment to help prevent skin rash

Dosage Modifications

If nadir ANC <500/mm³ & nadir platelets ≥50,000/mm³

  • Adjust to 75% of previous dose (both drugs)

If nadir platelets <50,000/mm³ regardless of nadir ANC

  • Adjust to 50% of previous dose (both drugs)

Any Grade 3 or 4 toxicities except mucositis

  • Adjust to 75% of previous dose (both drugs)

Any diarrhea requiring hospitalization

  • Adjust to 75% of previous dose (both drugs)

Grade 3 or 4 mucositis

  • Adjust Alimta to 50% of previous dose

CTC Grade 2

  • Adjust Cisplatin to 50% of previous dose

Monitor

CBC, platelet counts, and CrCl for nadir and recovery before each cycle

Periodic hepatic monitoring

Requirements to begin new cycle

  • ANC >1500 cells/mm³
  • Platelets >100,000 cells/mm³
  • CrCl ≥45 mL/min

Safety and efficacy not established

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Interactions

Interaction Checker

pemetrexed and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (84%)

            Fatigue (80%)

            Pulmonary dyspnea (66%)

            Neutropenia (58%)

            Vomiting (58%)

            Leukopenia (55%)

            Constipation (44%)

            Chest pain (40%)

            Anorexia (35%)

            Anemia (33%)

            Pharyngitis (28%)

            Stomatitis (28%)

            Thrombocytopenia (27%)

            Diarrhea without colostomy (26%)

            Rash/desquamation (22%)

            Fever (17%)

            Neuropathy/sensory (17%)

            Creatinine elevation (16%)

            Mood alteration/depression (14%)

            Infection without neutropenia (11%)

            1-10%

            Dehydration, thrombosis/embolism (7%)

            Dysphagia/esophagitis/odynophagia (6%)

            Infection with Grade 3 or Grade 4 neutropenia (6%)

            Neutropenia-other (3%)

            Allergic reaction/hypersensitivity (2%)

            Renal failure (2%)

            Febrile neutropenia (1%)

            <1%

            Esophagitis

            Arrhythmia

            Motor neuropathy

            Febrile neutropenia

            Erythema multiforme

            Postmarketing Reports

            Gastrointestinal: Colitis, pancreatitis

            Blood and lymphatic system: Immune-mediated hemolytic anemia

            General: Edema

            Injury, poisoning, and procedural complications: Radiation recall has been reported in patients who have previously received radiotherapy

            Respiratory: Interstitial pneumonitis

            Skin: Bullous conditions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (some cases were fatal)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Premedication required with folic acid PO and vitamin B12 IM to reduce severity of hematologic and GI toxicities; do not substitute PO vitamin B12 for IM to assure adequate absorption

            Renal impairment, bone marrow suppression (dose-limiting toxicity)

            Obtain a complete blood count and renal function tests at the beginning of each cycle and as needed; do not initiate a cycle of treatment unless the ANC is ≥1500 cells/mm³, the platelet count is ≥100,000 cells/mm³, and creatinine clearance is ≥45 mL/min

            Coadministration of NSAIDS with mild-to-moderate renal insufficiency; NSAIDs can decrease pemetrexed renal clearance

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not safe

            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

            Vdss: 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, Elimination: 3.5 hr

            Excretion: urine

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            Administration

            IV Incompatibilities

            Solution: diluents containing calcium, including LR & Ringer's

            Coadministration not recommended

            IV Compatibilities

            Solution: 0.9% NaCl

            IV Preparation

            Aseptically reconstitute with 20 mL of 0.9% NaCl (preservative free) to give a 25 mg/mL solution

            Gently swirl until completely dissolved; resulting solution is clear and ranges in color from colorless to yellow/green-yellow without adversely affecting quality

            Aseptically dilute required dose to 100 mL with 0.9% NaCl (preservative free)

            Reconstituted and infusion soln stable for 24 hr at room temperature and fridgerator

            IV Administration

            Infuse over 10 min

            Storage

            Store vials at 25°C (77°F)

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            Images

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            Formulary

            FormularyPatient Discounts

            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.
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            • Compare formulary status to other drugs in the same class.
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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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