Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously rece.
O que diz a bula oficial. Se um médico receitou, siga a receita. Se a bula da sua caixa for diferente, vale a da sua caixa.
Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Metastatic Breast Cancer Eribulin mesylate injection is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. …
Injection: 1 mg/2 mL (0.5 mg/mL) eribulin mesylate is a clear, colorless, sterile solution in a single-dose vial. Injection: 1 mg per 2 mL (0.5 mg per mL) eribulin mesylate in a single-dose vial ( 3 )
Study 1 did not include sufficient numbers of subjects with metastatic breast cancer aged 65 years and older to determine whether they respond differently from younger subjects. Of the 827 subjects who received the recommended dose and schedule of eribulin mesylate in clinical studies with advanced breast cancer, 15% (121/827) were 65 and older and 2% (17/827) patients were 75 and older. …
7.1 Effects of Other Drugs on Eribulin Mesylate No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P‑glycoprotein (P-gp) inhibitors. Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when eribulin mesylate was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-gp inhibitor) and when eribulin mesylate was administered with or without rifampin (a CYP3A4 inducer) [see Clinical Pharmacology ( 12.3 )]. …
Neutropenia : Monitor peripheral blood cell counts and adjust dose as appropriate. ( 5.1 ) Peripheral Neuropathy : Monitor for signs of neuropathy. Manage with dose delay and adjustment. ( 5.2 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) QT Prolongation : Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome. …
The most common adverse reactions (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. ( 6.1 ) The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade 3 to 4 laboratory abnormalities in liposarcoma and leiomyosarcoma were neutropenia, hypokalemia, and hypocalcemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …
8.1 Pregnancy Risk Summary Based on findings from an animal reproduction study and its mechanism of action, eribulin mesylate, can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no available data on the use of eribulin mesylate during pregnancy. …
Overdosage of eribulin mesylate has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for eribulin mesylate injection overdose.
Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.
Products with Eribulin as the active ingredient. Names differ between countries.
Type the registration number on the pack, or scan it with your camera.
Eribulin mesylate injection is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior a (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: Administer 1.4 mg/m 2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. ( 2.1 ) Reduce dose in patients with hepatic impairment or with moderate or severe renal impairment. ( 2.1 ) Do not mix with other drugs or administer with dextrose-containing solutions. ( 2.3 ) 2.1 Recommended Dose The recommended dose of eribulin mesylate injection is 1.4 mg/m 2 adminis…
Usually yes. Eribulin is a prescription medicine in most countries. Rules differ by country.
Eribulin is sold under names such as Halaven, Eribulin Mesylate. Brand names differ between countries.
The official label lists: The most common adverse reactions (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. ( 6.1 ) The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade… Tell your doctor about any side effect that bothers you or does not go away.
The safety and effectiveness of eribulin mesylate injection in pediatric patients have not been established. Pediatric use information describing clinical studies in which efficacy was not demonstrated is approved for Eisai Inc’s HALAVEN ® (eribulin mesylate) injection. However, due to Eisai Inc’s marketing exclusivity rights, this drug product is not labeled with that informat… Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Based on findings from an animal reproduction study and its mechanism of action, eribulin mesylate, can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no available data on the use of eribulin mesylate during pregnancy. … Ask your doctor or midwife first.
7.1 Effects of Other Drugs on Eribulin Mesylate No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P‑glycoprotein (P-gp) inhibitors. Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when eribulin mesylate was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-… Use the free interaction checker before combining medicines.
Overdosage of eribulin mesylate has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for eribulin mesylate injection overdose. Get medical help right away.
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.