TM Owner Eagle Pharmaceuticals, Inc.
Pemfexy 500mg Vial
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Indications & Clinical Uses
- Pemfexy 500 mg/20 mL is a ready-to-dilute solution of pemetrexed, made by Eagle Pharmaceuticals as a branded alternative to Alimta (pemetrexed disodium); unlike Alimta's lyophilised powder, Pemfexy does not require reconstitution, so the two products' preparation and dilution steps are not interchangeable.
- Pemfexy is a folate antimetabolite chemotherapy given by intravenous infusion.
- It is approved, in combination with cisplatin, for adults with previously untreated malignant pleural mesothelioma unsuitable for curative surgery and for previously untreated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
- It is also approved as single-agent maintenance therapy after platinum-based first-line chemotherapy, for previously treated non-squamous NSCLC, and, since 2022, in combination with pembrolizumab and platinum chemotherapy as first-line treatment for metastatic non-squamous NSCLC.
- Pemfexy is not approved for predominantly squamous-cell NSCLC and is given only in a hospital or oncology clinic.
Side Effects
- As with other pemetrexed products, the most common side effects of Pemfexy used alone are fatigue, nausea and loss of appetite, each affecting at least 1 in 5 people.
- With cisplatin, vomiting, low blood counts (neutropenia, anaemia, thrombocytopenia), mouth or throat soreness and constipation are also common; with pembrolizumab and platinum chemotherapy, fatigue, nausea, constipation, diarrhoea, reduced appetite, rash, vomiting, cough and fever are frequently reported.
- Pemfexy has no boxed warning, but it can cause serious bone marrow suppression, so blood counts are checked before every dose.
- Report fever, signs of infection, unusual bleeding or bruising, or severe mouth soreness immediately.
- Kidney function is monitored, since reduced clearance raises toxicity.
- Folic acid and vitamin B12 supplementation, given alongside every course, reduce the risk of severe toxicity and must not be missed.
- Seek urgent care for breathlessness or chest pain.
Precautions & Warnings
- Pemfexy is contraindicated in patients with a history of severe hypersensitivity reaction to pemetrexed.
- It must not be given if creatinine clearance is below 45 mL/min, because reduced kidney clearance significantly increases drug exposure and toxicity; kidney function is checked before every cycle.
- Folic acid (400-1000 micrograms daily) must start at least one week before the first dose and continue through treatment and for 21 days afterward; vitamin B12 is given by injection every three cycles; and dexamethasone is usually given the day before, of, and after each dose to reduce skin reactions.
- Complete blood counts are checked before each cycle.
- Unopened Pemfexy vials must be kept refrigerated at 2°C to 8°C, protected from light, and never frozen — unlike lyophilised pemetrexed powder, which is room-temperature stable before reconstitution.
- Pemfexy can cause fetal harm and should be avoided in pregnancy; effective contraception is advised during and after treatment.
Avoid Interactions
- Ibuprofen and other NSAIDs can raise pemetrexed exposure and should be avoided for two days before and after a Pemfexy dose in patients with mild to moderate kidney impairment (creatinine clearance 45-79 mL/min); patients with normal kidney function need closer monitoring if taking NSAIDs near dosing days.
- Nephrotoxic medicines may further reduce clearance and increase toxicity.
- Live vaccines should be avoided during treatment because of the risk of infection in an immunosuppressed patient.
- Tell your healthcare provider about all prescription and over-the-counter medicines, including pain relievers, and all supplements, before starting Pemfexy.
- Because Pemfexy is a pre-mixed liquid concentrate that still requires further dilution before infusion, it must only be diluted as directed and never mixed with calcium-containing or other incompatible intravenous solutions.
References
Frequently Asked Questions
Pemfexy (pemetrexed) is a chemotherapy medicine used with cisplatin for malignant pleural mesothelioma and non-squamous non-small cell lung cancer. It's also used alone as maintenance treatment, or with pembrolizumab and platinum chemotherapy, for advanced non-squamous lung cancer. It is made by Eagle Pharmaceuticals.
Pemfexy is given as an intravenous infusion, usually once every 3 weeks, in a hospital or cancer clinic. Unlike some pemetrexed products, Pemfexy is a ready-to-dilute liquid, not a powder. You'll also take folic acid daily and get vitamin B12 injections during treatment.
Common effects include fatigue, nausea and reduced appetite; with cisplatin, vomiting and low blood counts are also common. Pemfexy can cause serious bone marrow suppression, so blood counts are checked before every dose. Report fever, unusual bleeding, or infection signs right away.
Avoid ibuprofen and other NSAIDs around your infusion day, especially with reduced kidney function, as they raise pemetrexed levels. Avoid live vaccines during treatment. Tell your healthcare provider about every medicine and supplement you take before each cycle of Pemfexy.
Unopened Pemfexy vials must be refrigerated at 2°C to 8°C, protected from light, and never frozen. This differs from some other pemetrexed products supplied as powder. Your pharmacy or clinic handles storage and dilution; you do not store or prepare Pemfexy yourself.
No. Pemfexy can harm an unborn baby, so effective contraception is recommended during treatment and for a period after the last dose. Discuss family planning with your oncologist. Pemfexy is given only under specialist supervision in a hospital or clinic setting.
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