toremifene citrate 60 mg/1
toremifene citrate · TABLET · Rising Pharma Holdings, Inc.
toremifene citrate is a tablet containing toremifene citrate at 60 mg/1, taken oral. Manufactured by Rising Pharma Holdings, Inc..
Key Facts
- Brand Name
- toremifene citrate
- Generic Name
- toremifene citrate
- NDC Code (Product)
64980-404- Manufacturer
- Rising Pharma Holdings, Inc.
- Strength
- 60 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208813
- Marketing Start
- 01/18/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. Toremifene citrate tablets are an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The dosage of toremifene citrate tablets is 60 mg, once daily, orally. Treatment is generally continued until disease progression is observed. 60 mg once daily, orally ( 2 )
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to the drug ( 4.1 ) QT Prolongation, Hypokalemia, Hypomagnesemia ( 4.2 ) 4.1 Hypersensitivity to the Drug Toremifene citrate tablets are contraindicated in patients with known hypersensitivity to the drug. 4.2 QT Prolongation, Hypokalemia, Hypomagnesemia Toremifene should not be prescribed to patients with congenital/acquired QT prolongation (long QT syndrome), uncorrected hypokalemia, or uncorrected hypomagnesemia.
Drug Interactions
7 DRUG INTERACTIONS Drugs that decrease renal calcium excretion, e.g., thiazide diuretics, may increase the risk of hypercalcemia in patients receiving toremifene citrate tablets. ( 7.1 ) Agents that prolong QT should be avoided. ( 7.2 ) Coadministration with a strong CYP3A4 inducer may result in a relevant decrease in toremifene citrate tablets exposure and should be avoided. ( 7.3 ) Coadministration with a strong CYP3A4 inhibitor can result in a relevant increase in toremifene citrate tablets exposure and should be avoided. ( 7.4 ) CYP2C9 substrates with a narrow therapeutic index such as warfarin or phenytoin with toremifene citrate tablets should be used with caution and require careful monitoring. ( 7.6 ) 7.1 Drugs that Decrease Renal Calcium Excretion Drugs that decrease renal calcium excretion, e.g., thiazide diuretics, may increase the risk of hypercalcemia in patients receiving toremifene citrate tablets. 7.2 Agents that Prolong QT The administration of toremifene citrate tablets with agents that have demonstrated QT prolongation as one of their pharmacodynamic effects should be avoided. Should treatment with any of these agents be required, it is recommended that therapy …
Adverse Reactions
6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Most common adverse reactions are hot flashes, sweating, nausea and vaginal discharge. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Adverse drug reactions are principally due to the antiestrogenic actions of toremifene citrate tablets and typically occur at the beginning of treatment. The incidences of the following eight clinical toxicities were prospectively assessed in the North American Study. The incidence reflects the toxicities that were considered by the investigator to be drug related or possibly drug related. North American Study TOR60 TAM20 n = 221 n = 215 Hot Flashes 35% 30% Sweating 20% 17% Nausea 14% 15% Vaginal Discharge 13% 16% Dizziness 9% 7% Edema 5% 5% Vomiting 4% 2% Vaginal Bleeding 2% 4% Approximately 1% of patients receiving toremifene c…
Frequently Asked Questions
What is toremifene citrate used for?
toremifene citrate contains toremifene citrate. It is a tablet taken oral. Consult your doctor for specific uses.
Is toremifene citrate a controlled substance?
toremifene citrate is not classified as a controlled substance by the DEA.
What is the generic name for toremifene citrate?
The generic name for toremifene citrate is toremifene citrate. There are 1 other brand versions of toremifene citrate.
What is the NDC code for toremifene citrate 60 mg/1?
The NDC (National Drug Code) for toremifene citrate 60 mg/1 is 64980-404, listed by Rising Pharma Holdings, Inc..