Pemfexy

— THERAPEUTIC DISORDERS TREATED —
  • Respiratory and thoracic cancers

Pemfexy Generic Name & Formulations

General Description

Pemetrexed 500mg/20mL (25mg/mL); per vial; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Antifolate.

How Supplied

Multi-dose vial—1

Manufacturer

Generic Availability

NO

Pemfexy Indications

Indications

Metastatic nonsquamous non-small cell lung cancer (NSCC) with no EGFR or ALK genomic tumor aberrations, in combination with pembrolizumab and platinum chemotherapy as initial treatment. Locally advanced or metastatic nonsquamous NSCC: in combination with cisplatin as initial treatment, or as a single agent for maintenance in patients whose disease has not progressed after 4 cycles of platinum-based 1st-line chemotherapy. Treatment of patients with recurrent, metastatic nonsquamous NSCLC after prior chemotherapy, as a single agent. Malignant pleural mesothelioma: in combination with cisplatin, for the initial treatment of patients whose disease is unresectable or who are otherwise not candidates for curative surgery.

Limitations of Use

Not for the treatment of squamous cell NSCLC.

Pemfexy Dosage and Administration

Adult

Supplement with oral folic acid one week prior to 1st pemetrexed dose, continue during treatment, and for 21 days after the last dose. Supplement with intramuscular vitamin B12 one week prior to 1st pemetrexed dose and every 3 cycles thereafter. Pretreat with dexamethasone for 3 consecutive days, beginning the day before each pemetrexed dose. In combination regimens: give pemetrexed dose after pembrolizumab and prior to carboplatin or prior to cisplatin. CrCl ≥45mL/min: 500mg/m2 by IV infusion over 10mins on Day 1 of each 21-day cycle. In combination with pembrolizumab/platinum chemotherapy for NSCLC: treat for 4 cycles; after platinum-based therapy completion, give pemetrexed with/without pembrolizumab until disease progression or unacceptable toxicity. In combination with cisplatin for NSCLC: treat for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Maintenance, recurrent NSCLC, mesothelioma: continue until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children

Not established.

Pemfexy Contraindications

Not Applicable

Pemfexy Boxed Warnings

Not Applicable

Pemfexy Warnings/Precautions

Warnings/Precautions

See full labeling. Increased risk of myelosuppression without vitamin supplementation. Permanently discontinue if recurrent Grade 3 or 4 myelosuppression or non-hematologic toxicity after two dose reductions, Grade 3 or 4 neurologic toxicity, severe/life-threatening skin toxicity, interstitial pneumonitis, or signs of radiation recall occur. Obtain CBCs at the beginning of each cycle. Do not start a treatment cycle unless ANC is ≥1500cells/mm3, platelets ≥100,000cells/mm3, recovery of non-hematologic toxicity to Grade 0–2. Withhold if acute onset of new or progressive unexplained pulmonary symptoms occur. Monitor CBCs, platelets, renal function prior to each dose and during treatment. Renal impairment (CrCl <45mL/min). Severe third space fluid. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

Pemfexy Pharmacokinetics

Elimination

Renal. Half-life: 3.5 hours (with normal renal function).

Pemfexy Interactions

Interactions

Increased risk of toxicity with concomitant ibuprofen in renal impairment (CrCl 45–79mL/min): avoid for 2 days before, the day of, and 2 days following pemetrexed dose; if unavoidable, monitor more frequently for effects.

Pemfexy Adverse Reactions

Adverse Reactions

Fatigue, nausea, anorexia, vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, constipation; renal failure, interstitial pneumonitis, bullous and exfoliative skin toxicity.

Pemfexy Clinical Trials

See Literature

Pemfexy Note

Not Applicable

Pemfexy Patient Counseling

See Literature