Alimta

Alimta,

a trademark for pemetrexed.

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pemetrexed Warning - High-alert drug!

Alimta

Pharmacologic class: Folic acid antagonist

Therapeutic class: Antineoplastic, antimetabolite

Pregnancy risk category D

Action

Disrupts folate-dependent metabolic processes essential for cell replication

Availability

Powder for injection: 500 mg sterile lyophilized powder in single-use vials

⊘Indications and dosages

➣ Malignant pleural mesothelioma in patients whose disease is unresectable or who otherwise aren't eligible for curative surgery (given with cisplatin)

Adults: 500 mg/m² I.V. infusion over 10 minutes on day 1 of each 21-day cycle (given in combination with cisplatin infused over 2 hours starting approximately 30 minutes after pemetrexed administration ends)

➣ Non-small-cell lung cancer

Adults: 500 mg/m² I.V. infusion over 10 minutes on day 1 of each 21-day cycle

Dosage adjustment

• Hematologic toxicities, based on nadir absolute neutrophil and platelet counts
• Grade 2 to 4 neurotoxicity
• Grade 3 or higher nonhematologic toxicities (except neurotoxicity)
• Grade 3 or 4 diarrhea or any diarrhea requiring hospitalization
• Creatinine clearance below 45 ml/minute

Contraindications

• Severe hypersensitivity reaction to drug or its components

Precautions

Use cautiously in:
• hepatic or renal impairment, neurotoxicity
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Reconstitute 500-mg vial with 20 ml preservative-free normal saline solution injection, yielding 25 mg/ml. Gently swirl vial until powder dissolves completely.
• Further dilute appropriate volume of reconstituted solution to 100 ml with preservative-free normal saline solution injection; administer I.V. over 10 minutes.
• Know that drug is physically incompatible with diluents containing calcium, including Ringer's and lactated Ringer's solutions. Administration with other drugs and diluents isn't recommended.
• Administer I.V. only.
• As ordered, pretreat with dexamethasone (or equivalent) 4 mg P.O. twice daily on day before, day of, and day after pemetrexed administration to minimize cutaneous reactions.
• When administering with cisplatin, hydrate patient with 1 to 2 L fluid infused over 8 to 12 hours before and after cisplatin administration. Maintain adequate hydration and urine output for 24 hours.
• To reduce toxicity, ensure that patient receives at least five daily doses of low-dose folic acid or multivitamin with folic acid within 7 days before first pemetrexed dose. Folic acid therapy should continue throughout course of therapy and for 21 days after final dose. Patient also must receive one I.M. injection of vitamin B₁₂ during week before first pemetrexed dose and every three cycles thereafter.
• Discontinue drug if creatinine clearance is below 45 ml/minute or patient has hematologic or nonhematologic Grade 3 or 4 toxicity after two dosage reductions (except Grade 3 transaminase elevation).
• Withdraw drug immediately in patients with Grade 3 or 4 neurotoxicity.

Route	Onset	Peak	Duration
I.V.	Unknown	Unknown	Unknown

Adverse reactions

CNS: fatigue, sensory neuropathy, altered mood, depression

CV: thrombosis , embolism

EENT: pharyngitis

GI: nausea, vomiting, constipation, diarrhea without colostomy, dysphagia, esophagitis, pain on swallowing, stomatitis, anorexia

GU: renal failure

Hematologic: neutropenia, leukopenia, anemia, thrombocytopenia, febrile neutropenia

Hepatic: abnormal liver function

Musculoskeletal: myalgia, arthralgia

Respiratory: dyspnea

Skin: rash, desquamation, alopecia

Other: fever, dehydration, noncardiac chest pain, infection without neutropenia or with Grade 3 or Grade 4 neutropenia, edema, other constitutional symptoms, allergic reaction, hypersensitivity reaction

Interactions

Drug-drug. Ibuprofen: decreased pemetrexed clearance and increased concentration

Nephrotoxic agents: possible decrease in pemetrexed clearance

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, serum creatinine: increased

Creatinine clearance, hematocrit, hemoglobin, platelets, WBCs: decreased

Patient monitoring

• Monitor CBC and platelet counts frequently.
• Monitor renal and liver function tests and blood chemistry results (especially serum creatinine) periodically.
• Know that patients with mild to moderate renal insufficiency should avoid taking nonsteroidal anti-inflammatory drugs (NSAIDs) with short elimination half-lives (such as aspirin, diclofenac, and ibuprofen) for 5 days before, on day of, and for 2 days after pemetrexed administration. If concomitant NSAID use is necessary, monitor patient closely for toxicities (especially myelosuppression and renal and GI toxicity).
• Be aware that all patients should avoid NSAIDs with long half-lives (such as diflunisal, piroxicam, and sulindac) for at least 5 days before, on day of, and for 2 days after pemetrexed administration. If concomitant NSAID use is necessary, monitor patient closely for toxicities (especially myelosuppression and renal and GI toxicity).

Patient teaching

• Instruct patient to take folic acid and vitamin B₁₂ before and during therapy, as prescribed.
• Advise patient to drink ten 8-oz glasses of fluid and to urinate frequently during first 24 hours after therapy that includes cisplatin.
• Teach patient to recognize signs and symptoms of anemia and to contact prescriber if temperature above 100.4ºF (38ºC) develops.
• Tell patient to consult prescriber before taking products containing ibuprofen.
• Advise female with childbearing potential to avoid pregnancy during therapy.
• Instruct breastfeeding patient to stop breastfeeding during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

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Patient discussion about Alimta.

Q. After Taxol/Carbo, then Alimta, treatments stopped because tumors no longer shrinking. Anything else to try? I was diagnosed with Stage 3 lung cancer about 6 months ago. Because of the weakness of my lungs due to advanced COPD, the Oncologist ruled out surgery & radiation so Chemo was the only alternative. I am now under Hospice care.

A. this is a question that the oncologist should answer...there are a lot of chemo treatments out there- but not always firring to the type of lung caner. but i'm sure he would suggest them...
look- there's some treatments in clinical trials. check them out maybe there'll be something for you. look under the topic "research":
http://www.nlm.nih.gov/medlineplus/lungcancer.html#cat27