hycamtin
Pharmaranks rates Hycamtin 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Hycamtin (Topotecan Hydrochloride) is a medication used to treat Non-Small-Cell Lung Carcinoma, Uterine Cervical Neoplasms, Ovarian Neoplasms, Small Cell Carcinoma.
Topotecan Hydrochloride · by Sandoz
Available as a generic: Topotecan Hydrochloride
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Topotecan Hydrochloride
- Form
- Capsule, Injectable
- Strength
- Topotecan Hydrochloride EQ 4MG BASE/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Sandoz
- FDA application
- NDA020671
- FDA boxed warning
- Yes — see the boxed warning
What is Hycamtin?
From the FDA label:Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is ( S )-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1 H -pyrano[3’,4’:6,7] indolizino [1,2- b ]quinoline-3,14-(4 H ,12 H )-dione monohydrochloride. The molecular formula is C 23 H 23 N 3 O 5 •HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213ºC to 218ºC. Topotecan hydrochloride has the following structural formula: HYCAMTIN (topotecan) for injection, for intravenous use is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each 4 mg vial contains 4 mg topotecan hydrochloride as free base. The reconstituted solution ranges in color from yellow to yellow-green. Inactive ingredients are mannitol, 48 mg, and tartaric acid, 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5. topotecan hydrochloride chemical structure
How to use
Hycamtin is sold in more than one form (Capsule and Injectable), and each is dosed differently. The instructions below come from the FDA label for application NDA020671 — follow the label that came with the product you were actually prescribed.
Ovarian Cancer and Small Cell Lung Cancer: 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle ( 2.2 , 2.3 ) Cervical Cancer: 0.75 mg/m 2 by intravenous infusion over 30 minutes on Days 1, 2, and 3, with cisplatin 50 mg/m 2 on Day 1, of a 21-day cycle ( 2.4 ) Renal Impairment: Reduce dose if creatinine clearance (CLcr) 20 to 39 mL/min ( 2.6 ) 2.1 Important Safety Information Verify dosage using body surface area. Do not exceed a single dose of 4 mg intravenously. 2.2 Recommended Dosage for Ovarian Cancer The recommended dosage of HYCAMTIN for injection is 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. 2.3 Recommended Dosage for Small Cell Lung Cancer (SCLC) The recommended dosage of HYCAMTIN for injection is 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day cycle. 2.4 Recommended Dosage for Cervical Cancer The recommended dosage of HYCAMTIN for injection is 0.75 mg/m 2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3, in combination with cisplatin 50 mg/m 2 on Day 1, of a 21-day cycle. 2.5 Dosage Modifications for Adverse Reactions Hematologic Do not administer subsequent cycles of HYCAMTIN for injection until…
Side effects
The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1)] Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.2)] Extravasation and Tissue Injury [see Warnings and Precautions (5.3)] Ovarian Cancer The most common Grade 3 or 4 hematologic adverse reactions (incidence > 5%) were neutropenia, anemia, thrombocytopenia, and febrile neutropenia. ( 6.1 ) The most common (incidence > 5%) non-hematologic adverse reactions (all Grades) were nausea, vomiting, fatigue, diarrhea, and dyspnea. ( 6.1 ) SCLC The most common Grade 3 or 4 hematologic adverse reactions were (incidence > 5%) neutropenia, anemia, thrombocytopenia, and febrile neutropenia. ( 6.1 ) The most common (incidence > 5%) non-hematologic adverse reactions (all Grades) were asthenia, dyspnea, nausea, pneumonia, abdominal pain, and fatigue. ( 6.1 ) Cervical Cancer The most common Grade 3 or 4 hematologic adverse reactions were (incidence > 5%) neutropenia, anemia, and thrombocytopenia. ( 6.1 ) The most common (incidence > 25% and ≥ 2% higher than cisplatin alone) non-hematologic adverse reactions were pain, vomiting, and infection/febrile neutropenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
MYELOSUPPRESSION HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. HYCAMTIN can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts ( 2.4 , 5.1 ).
Warnings
Important safety information
Interstitial Lung Disease (ILD): Fatal cases have occurred. Permanently discontinue if ILD confirmed. ( 5.2 ) Extravasation and Tissue Injury: Severe cases have occurred. If extravasation occurs, immediately stop administration and institute recommended management procedures. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to the fetus and to use effectives contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Myelosuppression HYCAMTIN can cause severe myelosuppression. Single Agent Grade 4 neutropenia occurred in 78% of 879 patients, with a median duration of 7 days and was most common during Cycle 1 (58% of patients). Grade 4 neutropenia associated with infection occurred in 13% and febrile neutropenia occurred in 5%. Sepsis occurred in 4% of patients and was fatal in 1%. Grade 4 thrombocytopenia occurred in 27%, with a median duration of 5 days. Grade 3 or 4 anemia occurred in 37% of patients. Combination with Cisplatin Grade 4 neutropenia occurred in 48% and Grade 4 thrombocytopenia occurred in 7% of 147 patients. Grade 3 or 4 anemia occurred in 40% of patients. Topotecan can cause fatal typhlitis (neutropenic enterocolitis). Consider the possibility of typhlitis in patients presenting with fever, neutropenia, and abdominal pain. Administer the first cycle of HYCAMTIN for injection only to patients with a baseline neutrophil count of greater than or equal to 1,500/mm 3 and a platelet count greater than or equal to 100,000/mm 3 . Monitor blood counts frequently during treatment. Withhold and reduce dose of HYCAMTIN for injection based on neutrophil counts, platelet counts and hemoglobin levels [see Dosage and Administration (2.5)]. 5.2 Interstitial Lung Disease Interstitial lung disease (ILD), including fatalities, can occur with HYCAMTIN. Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic radiation, and use of pneumotoxic drugs or colony stimulating factors. Monitor for pulmonary symptoms indicative of ILD. Permanently discontinue HYCAMTIN for injection if ILD is confirmed. 5.3 Extravasation and Tissue Injury Extravasation, including severe cases, can occur with HYCAMTIN for injection. If signs or symptoms of extravasation occur, immediately stop administration of HYCAMTIN for injection and institute recommended management procedures [see Adverse Reactions (6.1)] . 5.4 Embryo-Fetal Toxicity Based on animal data, HYCAMTIN can cause fetal harm when administered to a pregnant woman. Topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of HYCAMTIN for injection. Advise males with a female partner of reproductive potential to use effective contraception during treatment with HYCAMTIN for injection and for 3 months after the last dose [see Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1)] .
Who should not take Hycamtin
HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)] . History of severe hypersensitivity reactions to topotecan ( 4 )
Overdose — what happens if you take too much
Overdoses (up to 10-fold of the recommended dose) have occurred in patients receiving intravenous topotecan. The primary complication of overdosage is myelosuppression. Elevated hepatic enzymes, mucositis, gastrointestinal toxicity, and skin toxicity have occurred with overdosages. If an overdose is suspected, monitor the patient closely for myelosuppression and institute supportive-care measures as appropriate.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
May treat (source: NIH RxClass)
Dosage forms
Capsule and Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Use copay cards
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Frequently asked questions
- What does Hycamtin treat?
- Hycamtin (Topotecan Hydrochloride) may be used to treat non-small-cell lung carcinoma, uterine cervical neoplasms, ovarian neoplasms, small cell carcinoma, small cell lung carcinoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Hycamtin rated?
- pharmaranks gives Hycamtin a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Hycamtin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Hycamtin. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Hycamtin?
- Hycamtin is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Hycamtin a brand-name or generic drug?
- Hycamtin is a brand-name product with the active ingredient Topotecan Hydrochloride. Lower-cost generic equivalents containing Topotecan Hydrochloride are available — ask your pharmacist.
- Is Hycamtin available over the counter?
- No. Hycamtin is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Hycamtin come in?
- Hycamtin is currently marketed as capsule and injectable, per the FDA's National Drug Code Directory.
- Is Hycamtin FDA-registered?
- Hycamtin is on record with the U.S. FDA under application number NDA020671. You can verify this on its official FDA label.
- Has Hycamtin been recalled by the FDA?
- Hycamtin has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Hycamtin safe?
- There's no single safe-or-not verdict. pharmaranks gives Hycamtin a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Hycamtin?
- Hycamtin's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1)] Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.2)] Extravasation and Tissue Injury [see Warnings and Precautions (5.3)] Ovarian Cancer The most com… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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hycamtin
68/100