NERLYNX 240 MG (NERATINIB)

What is Nerlynx?

Nerlynx is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Nerlynx is used alone or with other medicines to treat early-stage HER2-positive breast cancer. Nerlynx is also used to treat HER2-positive breast cancer that is advanced or has spread to other parts of the body (metastatic).

Nerlynx is used for breast cancer only if your tumor tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 protein can speed the growth of cancer cells.

📌 General Info

• Brand Name: Nerlynx

• Generic / Salt: Neratinib hydrochloride

• Drug Class: Irreversible dual HER2/EGFR tyrosine kinase inhibitor

• Manufacturer: Puma Biotechnology (licensed from Pfizer)

🩺 Indications

1. Extended adjuvant therapy: Early-stage HER2-positive breast cancer in adults, following trastuzumab-based treatment, to reduce recurrence risk

2. Metastatic HER2-positive breast cancer: In combination with capecitabine after at least two prior anti-HER2 therapies

💊 Dosage & Administration

Monotherapy (Adjuvant):

• 240 mg once daily (6×40 mg tablets), with food, for up to 1 year

• Diarrhea prevention (first 56 days): Loperamide 4 mg TID (weeks 1–2), then BID (weeks 3–8), then PRN (max 16 mg/day) accessdata.fda.gov.

Combination (Metastatic):

• Escalation: 120 mg daily (days 1–7), then 160 mg (days 8–14), then 240 mg daily (day 15 onward), alongside capecitabine cycles reference.medscape.com.

⚠️ Safety & Monitoring

Key Side Effects:

• Diarrhea (95 % incidence; 40 % severe)—monitor and manage aggressively with loperamide and hydration

• Gastrointestinal: Nausea, abdominal pain, vomiting, stomatitis, decreased appetite.

• Dermatologic: Rash, dry skin, nail disorders.

• Other: Fatigue, muscle spasms, elevated liver enzymes, UTI, weight loss .

Serious Risks:

• Dehydration, electrolyte imbalance, renal impairment—especially in older adults .

• Hepatotoxicity—monitor liver enzymes monthly for 3 months, then quarterly .

• QT prolongation? Low but monitor if risk.

Drug Interactions & Contraindications:

• Avoid PPIs/H2 antagonists, space antacids 3 h apart

• Strong CYP3A4 inhibitors ↑ neratinib levels (↑ side effects), inducers ↓ efficacy

• P-gp substrates: Monitor as neratinib inhibits P-gp

• Pregnancy/Breastfeeding: Contraindicated—use contraception during and for at least 1 month (women) or 3 months (men) post-treatment .

🇮🇳 Availability in India

• Not locally approved, but accessible via Named Patient Import through suppliers like Indian Pharma Network, Global Rare Meds, Specialty Pharma, Lucknow Speciality Pharma, Synergy Drugs.

• Requirements: Prescription, diagnostic & regulatory documents, import permission (Form 12A/12B).

• Pack sizes: Commonly available in 40 mg tablets, packs of 180 or more .

✅ Summary

Nerlynx (neratinib) is a powerful oral HER2-targeted therapy with proven benefit in reducing disease recurrence in early-stage breast cancer and as a treatment for metastatic cases. Diarrhea is the pivotal side effect, demanding proactive prophylaxis and hydration strategies. Regular monitoring of liver function, electrolytes, and GI symptoms is essential. In India, it’s available exclusively via import channels, requiring careful coordination between physician, patient, and supplier.