Pemetrexed

Registered South African indications:

• Malignant pleural mesothelioma
• Non-small cell lung cancer
• Adenocarcinoma of the lung

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Coadministration with yellow fever vaccine

Cautions

• Pregnancy
• Women of childbearing potential
• Breastfeeding
• Males of reproductive potential
• Moderate to severe renal impairment
• Third-space fluid
• Dehydration
• Cardiovascular risk factors 
• Previous radiotherapy
• Sperm storage
• Sexually active individuals
• Sodium controlled diet
• May impair ability to drive and operate machinery
• Concomitant use of live attenuated vaccines

Forms avail. in SA and covered in this monograph: inj

Used for the treatment of

Malignant pleural mesothelioma (additional agent required)
Non-small cell lung cancer (additional agent required)
- Locally advanced or metastatic, other than that predominantly squamous cell histology 
Adenocarcinoma of the lung
- Locally advanced or metastatic after prior chemotherapy
- Locally advanced or metastatic, in patients whose disease has not progressed immediately following standard chemotherapy

Consult specialist for dosages and regimens

Not established for use in children below 18 years

Pregnancy

• Caution; positive evidence of risk in animal studies
• There is no data on the use of pemetrexed in pregnant women but pemetrexed, like other antimetabolites, is suspected to cause serious birth defects when administered during pregnancy
• Animal studies have shown reproductive toxicity. Pemetrexed should not be used during pregnancy due to the potential hazard to the foetus. Women should also be advised to avoid becoming pregnant while being treated with pemetrexed

Women of childbearing potential / contraception in males and females

• Women of childbearing potential must use effective contraception during treatment with pemetrexed
• Pemetrexed can have genetically damaging effects. Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter. Contraceptive measures or abstinence are recommended

Breastfeeding

• Caution; not recommended
• It is not known whether pemetrexed is excreted in human milk and adverse reactions on the breastfeeding child cannot be excluded
• Breastfeeding must be discontinued during pemetrexed therapy

Fertility

• Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting pemetrexed treatment

Renal Impairment

• Moderate to severe: Caution; dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Central Nervous System Disorders

• Sensory neuropathy
• Fatigue

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting
• Stomatitis
• Pharyngitis
• Anorexia
• Constipation
• Dyspepsia

Hepatobiliary Disorders

• Elevated hepatic enzymes

Genitourinary Disorders

• Increased creatinine 
• Decreased creatinine clearance 

Endocrine and Metabolic Disorders

• Dehydration

Skin and Subcutaneous Tissue Disorders

• Rash
• Pruritus
• Alopecia

Immune, Blood and Lymphatic System Disorders

• Decreased neutrophils
• Decreased granulocytes 
• Decreased leukocytes 
• Decreased haemoglobin 
• Decreased platelets 
• Fever

Sensory Disorders

• Taste disturbance
• Conjunctivitis
• Oedema

• Yellow fever vaccine
• Live attenuated vaccines 
• Nephrotoxic agents
• Tubularly secreted agents
• Non-steriodal anti-inflammatory drugs
• Acetylsalicylic acid
• Oral anticoagulants

• Full blood count with differential
• Renal function
• Hepatic function

Specific cases may require

• International normalized ratio

Pre-medication regimen

• In case of cisplatin-based regimens, patients must receive adequate anti-emetic treatment and appropriate hydration prior to and/or after receiving cisplatin
• To reduce toxicity, patients must take oral folic acid or a multivitamin containing folic acid. Patients must also receive an intramuscular injection of vitamin B12
• To reduce the incidence and severity of skin reactions, a corticosteroid should be given the day prior to, on the day of, and the day after pemetrexed administration

Pemetrexed is a multitarget anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell-replication.

Injection (per vial) 100mg

• Alimta 100 (Eli Lilly) originator
• Extreda 100 ( Adven Pharma)
• Pemetrexed Accord 100 (Accord Healthcare)
• Pexali 100 (Abex Pharmaceutica)

Injection (per vial) 500mg

• Alimta 500 (Eli Lilly) originator
• Extreda 500 ( Adven Pharma)
• Pemetrexed Accord 500 (Accord Healthcare)
• Pemetrexed Cipla 500 (Cipla)
• Pemject (Lamar International)
• Pexali 500 (Abex Pharmaceutica)
• Pexitaz 500 (Ranbaxy Pharmaceuticals)
• Terexta 500 (Accord Healthcare)