Oral topotecan hydrochloride

What is Oral topotecan hydrochloride?

• Oral topotecan hydrochloride (Hycamtin Capsules) is a topoisomerase inhibitor used for the treatment of patients with relapsed small cell lung cancer (SCLC).

Topotecan Structural Formula V.1

Topotecan2DACS

What are the uses of this medicine?

Oral topotecan hydrochloride (Hycamtin Capsules) is a prescription medicine used to treat small cell lung cancer (SCLC) that has come back (relapsed) and:

• the cancer responded to your first chemotherapy, and
• it has been at least 45 days from the last dose of chemotherapy.

How does this medicine work?

• Topotecan binds to the topoisomerase I-DNA complex and prevents re-ligation of these single-strand breaks.
• During the S phase of the cell cycle, topotecan selectively stabilizes topoisomerase I-DNA covalent complexes, inhibiting religation of topoisomerase I-mediated single-strand DNA breaks and producing potentially lethal double-strand DNA breaks when complexes are encountered by the DNA replication machinery.
• Camptothecin is a cytotoxic quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to topotecan or any of the ingreidents in HYCAMTIN.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• Taking HYCAMTIN with certain other medicines can affect how HYCAMTIN works causing side effects.

Is this medicine FDA approved?

• Initial U.S. Approval: 1996

How should this medicine be used?

Recommended dosage:

• The recommended dosage of HYCAMTIN capsules is 2.3 mg/m2/day orally once daily, with or without food, for 5 consecutive days, starting on Day 1 of a 21-day cycle.

Renal Impairment:

• Reduce dose if creatinine clearance (CLcr) less than 50 mL/min.

Administration:

• Swallow capsules whole.
• Do not chew, crush, or divide the capsules.
• If a dose of HYCAMTIN capsules is missed or vomiting occurs after taking a dose, do not administer an additional dose and take the next dose at the scheduled time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 0.25 mg or 1 mg

This medicine is available in fallowing brand namesː

• Hycamtin

What side effects can this medication cause?

The most common side effects of this medicine include:

• decreased blood cell counts
• diarrhea
• hair loss
• nausea
• vomiting
• fatigue
• HYCAMTIN may cause short-term and long-term fertility problems in females.
• HYCAMTIN may cause lower sperm count problems in men.

HYCAMTIN may cause serious side effects, including:

• Bone marrow problems
• Diarrhea
• Lung problems that can cause death

What special precautions should I follow?

• HYCAMTIN can cause severe myelosuppression. Withhold and reduce dose of HYCAMTIN capsules based on neutrophil counts, platelet counts and hemoglobin levels.
• Diarrhea, including severe and life-threatening diarrhea requiring hospitalization, can occur with HYCAMTIN capsules. Withhold and reduce dose as recommended.
• Interstitial lung disease (ILD), including fatalities, can occur with HYCAMTIN. Permanently discontinue if confirmed ILD.
• Based on animal data, HYCAMTIN can cause fetal harm when administered to a pregnant woman. Advise patients of potential risk to the fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• myelosuppression
• Mucositis

Management of overdosage:

• If an overdose is suspected, monitor the patient closely for myelosuppression and institute supportive-care measures as appropriate.

Can this medicine be used in pregnancy?

• Based on animal data and its mechanism of action, HYCAMTIN can cause fetal harm when administered to a pregnant woman.
• There are no available clinical data on the use of HYCAMTIN in pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• topotecan hydrochloride

Inactive ingredients:

• gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The 1-mg capsules also contain red iron oxide. The capsules are imprinted with edible black ink.

Who manufactures and distributes this medicine?

Distributed by:

• Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store HYCAMTIN in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep the bottle of HYCAMTIN in the carton that it comes in to protect it from light.

• Dailymed label info on Oral topotecan hydrochloride
• FDA Oral topotecan hydrochloride