Comcapsy Capecitabine and Cyclophosphamide Tablets

Generic Name: Capecitabine and Cyclophosphamide Tablets

English Name: Capecitabine and Cyclophosphamide Tablets

Brand Name: Comcapsy

Specifications: 400 mg/20 mg (Capecitabine 400 mg + Cyclophosphamide 20 mg) — 14 tablets/box

700 mg/30 mg (Capecitabine 700 mg + Cyclophosphamide 30 mg) — 28 tablets/box

Manufacturer: Intas Pharmaceuticals Ltd. (India)

[Description]

Film-coated tablets; white or off-white in color after removal of the coating.

[Pharmacology and Toxicology]

Capecitabine: A prodrug of fluorouracil (5-FU); it is converted into 5-FU within tumor tissue, thereby inhibiting DNA synthesis and preventing the division and proliferation of tumor cells.

Cyclophosphamide: An alkylating agent that induces cross-linking of DNA strands, disrupting DNA structure and function, and inducing apoptosis in tumor cells.

Synergistic Action: When combined, the two drugs act upon different phases of the tumor cell cycle, thereby enhancing anti-tumor activity.

[Indications]

Used for the chemotherapy of advanced solid tumors, including metastatic breast cancer, colorectal cancer, gastric cancer, ovarian cancer, etc.

Primarily indicated for: Metastatic breast cancer (first-line/second-line treatment);

Colorectal cancer (postoperative adjuvant therapy or advanced palliative care);

Advanced gastric cancer, pancreatic cancer, and other gastrointestinal tumors.

[Dosage and Administration]

Administration Method: Administer orally within 30 minutes after a meal. Swallow the tablet whole; do not crush or chew.

Standard Dosage (Comcapsy 400 mg/20 mg):

Twice daily (once in the morning and once in the evening); 

1 tablet per dose;

Take continuously for 14 days, followed by a 7-day drug-free interval; one cycle consists of 21 days.

Dosage Adjustment: Based on blood counts, hepatic and renal function, or the occurrence of adverse reactions, the dosage may be reduced or treatment temporarily suspended at the discretion of a physician. 【Adverse Reactions】

1. Very Common (≥10%)

Gastrointestinal: Nausea, vomiting, diarrhea, stomatitis, decreased appetite

Skin: Hand-foot syndrome (numbness, redness/swelling, peeling), alopecia

Hematologic: Leukopenia, neutropenia, anemia, thrombocytopenia

Systemic: Fatigue, fever, flu-like symptoms

2. Common (1%–10%)

Abnormal liver/renal function, elevated bilirubin

Dizziness, headache, insomnia, dysgeusia (altered taste)

Bleeding tendency, epistaxis (nosebleed), increased risk of infection

Cystitis (hematuria, urinary frequency, dysuria)

3. Uncommon/Rare

Cardiotoxicity (arrhythmias, myocardial ischemia), interstitial pneumonia

Severe hypersensitivity reactions, severe bone marrow suppression, hemorrhagic cystitis, hepatic failure

【Contraindications】

Patients with known hypersensitivity to capecitabine, cyclophosphamide, or any of the excipients

Severe bone marrow suppression (neutrophil count < 1.5 × 10⁹/L; platelet count < 100 × 10⁹/L)

Severe hepatic and/or renal impairment

Pregnant or breastfeeding women

Active severe infection, varicella (chickenpox), or herpes zoster (shingles)

【Precautions】

1. Hematologic Monitoring: Perform a complete blood count (CBC) prior to each treatment cycle and during therapy; discontinue the drug or reduce the dosage in cases of Grade III/IV bone marrow suppression.

2. Hepatic and Renal Function: Periodically monitor liver enzymes, creatinine, and blood urea nitrogen (BUN); use with caution or reduce the dosage in patients with hepatic and/or renal impairment.

3. Hand-Foot Syndrome: If numbness, pain, or peeling of the hands and feet occurs, discontinue the drug and provide symptomatic treatment.

4. Cystitis: Encourage increased fluid intake and urine alkalinization; discontinue the drug immediately if hematuria occurs.

5. Contraception: Both male and female patients must practice strict contraception during treatment and for 6 months following the discontinuation of the drug.

6. Vaccines: The use of live vaccines is contraindicated during treatment and for 3 months following the discontinuation of the drug.

7. Driving/Operating Machinery: The drug may cause dizziness or fatigue; patients should avoid engaging in high-risk activities such as driving or operating heavy machinery. [Drug Interactions]

Concomitant use with Warfarin or Phenytoin: Enhances anticoagulant/antiepileptic effects; prothrombin time monitoring is required.

Concomitant use with myelosuppressive agents or radiotherapy: Exacerbates myelosuppression.

Concomitant use with hepatic enzyme inducers/inhibitors (e.g., Rifampin, Cimetidine): Affects drug metabolism.

Allopurinol: May exacerbate the myelotoxicity of Cyclophosphamide.

[Use in Pregnancy and Lactation]

Pregnancy: Category D (Teratogenic Risk); contraindicated.

Lactation: The drug may be excreted into breast milk; contraindicated.

[Pediatric Use]

Safety and efficacy have not been established; use is not recommended.

[Geriatric Use]

Patients >65 years of age experience a higher incidence of adverse reactions (particularly myelosuppression and gastrointestinal effects); dosage reduction and intensified monitoring are required.

[Overdosage]

Manifestations: Severe vomiting, diarrhea, bone marrow failure, hemorrhage, infection, and hepatic/renal impairment.

Management: Discontinue the drug immediately; perform gastric lavage and provide symptomatic supportive care (including anti-infective therapy, blood transfusion, hematopoietic growth factors, and hepatic/renal protection).

[Storage]

Keep tightly sealed; store in a cool, dry place (<25°C), protected from light and moisture.

[Shelf Life]

24 months

Product Specifications

Product Name: Comcapsy Capecitabine and Cyclophosphamide Tablets