HYCAMTIN (Topotecan)

HYCAMTIN capsules are the oral form of topotecan, a chemotherapy medicine for small cell lung cancer (SCLC) that has come back after first-line treatment. The US label covers patients who had a complete or partial response to their first chemotherapy and who are at least 45 days past the end of it. In Europe and the UK the capsules are licensed as single-agent treatment for adults with relapsed SCLC when repeating the first-line regimen is not considered suitable.

Topotecan blocks topoisomerase I, an enzyme that briefly cuts one strand of DNA so the coil can unwind during copying. The drug holds the enzyme on the DNA and prevents the cut from being sealed again; when the cell then tries to copy its DNA, these trapped breaks turn into double-strand damage that the cell cannot survive. About 40% of a swallowed dose is absorbed.

In the trial behind the US approval, 141 patients with relapsed SCLC who were not candidates for intravenous chemotherapy received either the capsules plus best supportive care or supportive care alone. Median survival was 6.0 months with the capsules and 3.2 months without them (hazard ratio 0.64). The European product information also reports two studies comparing the capsules with intravenous topotecan, in which response rates and survival were broadly similar.

The main advantage of the capsule is that it is taken at home instead of during five daily hospital visits for an infusion. Other second-line SCLC options your oncologist may consider include Zepzelca (lurbinectedin) and Imdelltra (tarlatamab); our article on extensive-stage small cell lung cancer treatment explains where each fits.

• Boxed warning, bone marrow suppression: topotecan can severely lower blood counts. The first cycle is given only if neutrophils are at least 1,500/mm³ and platelets at least 100,000/mm³, and later cycles only once neutrophils are above 1,000/mm³, platelets above 100,000/mm³ and haemoglobin at least 9 g/dL. Across 682 patients, 32% had grade 4 neutropenia; infection occurred in 17% and 1% died of sepsis.
• Fever, low white cells and stomach pain together can signal typhlitis, an inflammation of the bowel wall that has been fatal; this needs immediate medical attention.
• Diarrhoea affected 22% of patients and was severe in about 4%, starting a median of 9 days into the cycle. It was more common in people aged 65 or older. A cycle should not be taken during severe diarrhoea, and the next dose is reduced by 0.4 mg/m² a day after recovery.
• Lungs: interstitial lung disease, sometimes fatal, has been reported. New cough, fever or breathlessness should be reported promptly; topotecan is stopped permanently if ILD is confirmed.
• Kidneys: the dose is cut to 1.5 mg/m² a day when creatinine clearance is 30–49 mL/min and to 0.6 mg/m² a day below 30 mL/min.
• Medicines that block the P-gp or BCRP transporters raise the amount of topotecan in the blood (about 2.5-fold in one study) and should be avoided with the capsules; ciclosporin is one such medicine, so share your full medicine list with the oncologist.
• Pregnancy must be ruled out before starting. Women should use contraception during treatment and for at least 6 months afterwards; men with a female partner who could conceive should do so for 3 months. Breastfeeding is not advised during treatment and for 1 week after the last dose.
• In the supportive-care trial the most frequent side effects were anaemia (94%), low neutrophils (91%), low platelets (81%), nausea (27%), vomiting (19%) and diarrhoea (14%).

How many capsules make up one cycle?

The starting dose is 2.3 mg per square metre of body surface once a day for 5 days, repeated every 21 days, rounded to the nearest 0.25 mg. For an adult of about 1.7 m² that works out to 4 mg a day, which is four 1 mg capsules, so one cycle uses 20 capsules or two bottles of 1 mg. The 0.25 mg strength lets the doctor fine-tune doses after a reduction. If a dose is vomited, it is not repeated; the next one is taken at the usual time.

Which papers should the patient keep ready?

• Oncologist’s prescription giving body surface area, daily dose in mg and the capsule strengths
• Pathology report confirming small cell lung cancer and a note of the first-line chemotherapy and its end date
• Recent blood counts and serum creatinine, which the doctor needs before every cycle
• Patient ID and delivery address

With these we can place the import in the patient’s name and plan bottles cycle by cycle.

How should HYCAMTIN capsules be stored and handled?

Keep the bottle in its carton in a refrigerator at 2–8 °C, away from light, and do not freeze it; shipments therefore travel in cold-chain packs. The capsules contain a cytotoxic drug, so they are swallowed whole and never opened, crushed or chewed. Carers should not touch a broken capsule with bare hands, and any skin contact should be washed off with soap and water.

Is oral topotecan sold in India?

Topotecan injection is available in India from Indian manufacturers, but we could not find any oral topotecan capsule on Indian pharmacy listings (checked November 2026), and no generic capsule is listed in the US either. When a doctor prefers treatment by mouth at home, the capsule has to be imported.

On DailyMed, Sandoz’s HYCAMTIN is the only topotecan capsule listed for the US market, and Sandoz also supplies the European and UK packs. Because each cycle depends on blood counts, start dates often move by a few days, so it helps to tell us the planned cycle date and the dose for that cycle as soon as the oncologist confirms them. Bottles come in their original sealed cartons from authorised distributors and are kept refrigerated in transit.

For HYCAMTIN capsule price in India or to place an order, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, ring the toll-free number 1800 1200 365, or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: capsules approved by the FDA on 11 October 2007 (NDA 020981), currently held by Sandoz; the intravenous form dates from 1996.
• European Union: Hycamtin has been authorised since November 1996; the capsules were added in March 2008. Sandoz Pharmaceuticals d.d. is the licence holder.
• United Kingdom: Hycamtin 0.25 mg and 1 mg hard capsules, Sandoz Limited; product information revised August 2026.
• India: topotecan injection is marketed; no oral capsule found.

Sources:

• HYCAMTIN capsules US Prescribing Information, DailyMed
• Drugs@FDA: NDA 020981
• EMA: Hycamtin EPAR
• UK SmPC, Hycamtin 1 mg hard capsules (eMC)

Information last checked: November 2026.

What are HYCAMTIN capsules used for?

Small cell lung cancer that has relapsed after first-line chemotherapy.

How is the oral form taken?

Once a day for five days in a row, then a break, repeating every 21 days. Capsules can be taken with or without food and are swallowed whole.

What kind of drug is topotecan?

A topoisomerase I inhibitor, a type of chemotherapy that stops cancer cells repairing the DNA breaks needed for copying.

Why are blood tests needed before each cycle?

Low neutrophil and platelet counts are the main risk, so the doctor checks them and kidney function before every cycle and adjusts the dose.

Who makes HYCAMTIN capsules?

Sandoz markets them; they are manufactured by GlaxoSmithKline Manufacturing in Parma, Italy.

Are HYCAMTIN capsules FDA approved?

Yes, since October 2007.