Updated study information from guidelines and package insert. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Topotecaninduced neutropenia can lead to neutropenic colitis. Posology when topotecan is used in combination with cisplatin, the full prescribing information for. Topotecan injection is supplied as singleuse vial containing 4 mg4 ml as a 1 mgml solution. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cellsmm 3 and platelet counts greater than or equal to. Dailymed topotecan hydrochloride injection, powder. Ndc 0078067461 package of 1 store between 20c and 25c 68f and 77f see usp controlled room temperature in original carton. Mozobil plerixafor injection, for subcutaneous use. Highlights of prescribing information platinumresistant. The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy. After reconstitution, it should be administered by intramuscular im. Each bag contains the following inactive ingredients.
Highlights of prescribing information these highlights do not include all the information needed to use topotecan injection safely and effectively. When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. Highlights of prescribing information these highlights do not include all the information needed to use hycamtin capsules safely and effectively. Side effect rates for hycamtin topotecan 0 reports. Myelosuppression see full prescribing information for complete boxed warning. Oct 01, 2019 hycamtin for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder for reconstitution in 4mg free base singledose vials. Topotecan for injection page 5 of 27 topotecan hydrochloride has been shown to be genotoxic to mammalian cells mouse lymphoma cells and human lymphocytes in vitro, and mouse bone marrow. Xgevadenosumab injection, for subcutaneous use initial usapproval. Monitor patients for symptoms and discontinue hycamtin if the diagnosis is confirmed.
After reconstitution of vial, gently mix solution 4. Hycamtin fda prescribing information, side effects and uses. Nov 01, 2019 topotecan hydrochloride can cause severe myelosuppression. These are side effects of hycamtin topotecan reported to the fda by people taking it, and by doctors and pharmacists. Hycamtin topotecan capsules, for oral use initial u. Topotecan is a pyranoindolizinoquinoline used as an antineoplastic agent. Transfer solution from each vial into a 2 ounce amber bottle 5. Hycamtin 4 mg powder for injection, singledose vial 00780674xx generics available from numerous manufacturers vii. Each 1 ml contains topotecan hydrochloride equivalent to 1 mg of topotecan free base. Hycamtin has been associated with reports of interstitial lung disease. Pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv.
It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Topotecan hydrochloride for injection hycamtin 4 mg mylan. Topotecan 4 mg injection 2 vials sterile water 8 ml directions. Pegasys monotherapy is only indicated for the treatment of patients with chc and compensated liver disease if there are contraindications or significant intolerance to other hcv antiviral drugs. Topotecan is a chemotherapy drug which can be used to treat ovarian cancer, small cell lung cancer and cervical cancer.
Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500mm3 and platelet counts greater than or equal to 100,000mm3. Do not give hycamtin to patients with baseline neutrophil counts less than 1,500 cells. Highlights of prescribing information these highlights do not include all theinformation needed to use xgevasafely and effectively. Topotecan is a semisynthetic, water soluble derivative of camptothecin, which is a cytotoxic alkaloid extracted from plants such as camptotheca acuminata. Hycamtin topotecan hydrochloride is a semisynthetic derivative of camptothecin and is an antitumor drug with topoisomerase iinhibitory activity. Sep 12, 2019 pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product.
Do not use if the oxygen indicator has turned blue or purple before opening the package see how suppliedstorage and handling 16. Hycamtin topotecan for injection, for intravenous use. Topotecan for injection page 4 of 27 warnings and precautions general topotecan for injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. See full prescribing information for hycamtin capsules. Prior to administration of the first course of topotecan. Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Follow applicable special handling and disposal procedures. It is a derivative of camptothecin and works by binding to the topoisomerase idna complex and preventing religation of these 328 single strand breaks. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to. See the fda package insert see pregnancy safe medications. A multicenter phase ii trial of intrathecal topotecan in. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as camptotheca acuminata or is. Once the overwrap package is opened, use within 24 hours see storage and handling 16.
Topotecan interferes with the function of an enzyme called topoisomerase i used by cells to repair breaks in the dna the machinery or brain that runs each cell strand. The data in warnings and precautions reflect exposure to topotecan hydrochloride for injection from eight trials in which 879 patients with ovarian cancer or small cell lung cancer sclc. Topotecan hydrochloride can cause severe myelosuppression. Topotecan is used to treat ovarian cancer, small cell lung cancer and cervical cancer. Mylan manufactures topotecan hydrochloride for injection hycamtin in strengths of 4 mg. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases.
Dailymed pentam 300 pentamidine isethionate injection. Vials of vinblastine sulfate for injection usp contain 10 mg. Topotecan hydrochloride is approved to be used alone or with other drugs to treat cervical cancer that has not gotten better with. The pka values obtained for the quinoline, phenol and benzyldimethylamino groups of topotecan tydrochloride were 0. This includes any possible side effects not listed in this leaflet see section 4. Updated fda approved indication for hycamtin capsules and injection. Per topotecan package insert, dilute each vial with 4 ml of sterile water for a final concentration of 1 mgml 3.
Pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product. Fda label information for this drug is available at dailymed. Highlights of prescribing information pegasyssafely and. Topotecanshould only be administered under the supervision of a physician experienced in the use of chemotherapy see section 6. Topotecan hydrochloride for injection hycamtin 4 mg. Topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions e. Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy see section 6. See full prescribing information for complete boxed warning. The pka values obtained for the quinoline, phenol and benzyldimethylamino groups of topotecan tydrochloride were. Hycamtin topotecan for injection, for intravenous use initial u. Administer only to patients with baseline neutrophil counts of greater than or equal to 1,500 cellsmm 3 and platelet counts greater than or equal to 100,000 cellsmm 3. Jul 21, 2019 ancobon prescribing information pdf package insert flucytosine ancobon is a the appropriate approved prescribing information should be consulted.
Camptosar is intended for dilution with 5% dextrose injection, usp d5w, or 0. The clinical formulation is supplied in a sterile form for intravenous use only. Topotecan actavis, inntopotecan european medicines agency. Hycamtin for injection,in combination with cisplatin,is indicated for the treatment of patients with stage ivb, recurrent, or persistent cervical cancernot amenable to curative treatment. Posology when topotecan is used in combination with. Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. What topotecan 1 mgml concentrate for solution for infusion. Topotecan is a yellow to green powder with a solubility in water of 80. It inhibits the action of topoisomerase i, an enzyme that produces reversible singlestrand breaks in dna during dna replication.
Pegasys in combination with ribavirinis indicated for the treatment of pediatric patients 5. Hycamtin for injection is supplied as a sterile lyophilized, buffered, light yellow to greenish powder available in singledose vials. Topotecanshould only be administered under the supervision of a physician. Etopophos solutions may be administered at infusion rates up to 3. Click on the topotecan hycamtin package insert below for reported side effects and possible drug interactions. It is a derivative of camptothecin and works by binding to the topoisomerase idna complex and preventing religation of. Monitor blood cell counts see warnings and precautions 5. When topotecan is used in combination with cisplatin, the full prescribing information for. Lcysteine hydrochloride hydrate 10 mg, sodium bisul. Bone marrow suppression, primarily neutropenia, is the dose limiting toxicity. See full prescribing information for topotecan injection. Mvasi, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Topotecan has the same mechanism of action as irinotecan. Topotecan fda prescribing information, side effects and uses.
After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. Neoplastic meningitis nm is a devastating complication of both hematologic and solid tumors, and is estimated to occur in 5%8% of cancer patients. Topotecan topotecan this product information is intended only for residents of the united states. Per topotecan package insert, dilute each vial with 4 ml of sterile water for a final concentration of 1. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Forhycamtin for injection in combination with cisplatin, reduce the dose to 0. It is best to read this information with our general information about chemotherapy and the type of cancer you have.
Each ml of the sterile solution contains 20 mg of plerixafor. Side effect videos nausea and vomiting diarrhea hair loss fatigue anemia neutropenic fever see dailymed package insert. Posology when topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Because the vials contain no preservative, contents should be used immediately after reconstitution. Refractory testicular tumors, in combination with other chemotherapeutic drugs. Mar 19, 2007 neoplastic meningitis nm is a devastating complication of both hematologic and solid tumors, and is estimated to occur in 5%8% of cancer patients. The preferred diluent is 5% dextrose injection, usp.
Hycamtin topotecan hydrochloride for injection initial u. Form m01unopened vials of topotecan hydrochloride are stable until the date indicated on the package when stored between 20 and 25c 68 and 77f see usp and protected from light in the original carton. Jan 29, 2020 the data in warnings and precautions reflect exposure to topotecan hydrochloride for injection from eight trials in which 879 patients with ovarian cancer or small cell lung cancer sclc received topotecan hydrochloride for injection 1. Topotecan injection is indicated for the treatment of patients with small cell lung cancer sclc. Topotecan injection, solution, concentrate dailymed. Etopophos is a topoisomerase inhibitor indicated for the treatmentof patients with. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy.