Frindovyx 500 mg/mL

Cyclophosphamide · INJECTION · Avyxa Pharma, LLC

No Recall History

Plain English

Frindovyx is a injection containing cyclophosphamide at 500 mg/mL, taken intravenous. Manufactured by Avyxa Pharma, LLC.

Key Facts

Brand Name: Frindovyx
Generic Name: Cyclophosphamide
NDC Code (Product): 83831-119
Manufacturer: Avyxa Pharma, LLC
Strength: 500 mg/mL
Dosage Form: INJECTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA210852
Marketing Start: 03/19/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use15,866 reports

febrile neutropenia14,218 reports

neutropenia10,341 reports

drug ineffective10,334 reports

pyrexia9,067 reports

disease progression7,924 reports

pneumonia6,510 reports

product use in unapproved indication6,446 reports

thrombocytopenia6,350 reports

nausea6,104 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Malignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin's disease, lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma Burkitt's lymphoma multiple myeloma leukemias: chronic lymphocytic leukemia, chronic granulocytic leukemia (it is usually ineffective in acute blastic crisis), acute myelogenous and monocytic leukemia, acute lymphoblastic (stem-cell) leukemia (cyclophosphamide given during remission is effective in prolonging its duration) mycosis fungoides (advanced disease) neuroblastoma (disseminated disease) adenocarcinoma of the ovary retinoblastoma carcinoma of the breast Cyclophosphamide, although effective alone in susceptible malignancies, is more frequently used concurrently or sequentially with other antineoplastic drugs. FRINDOVYX is an alkylating drug indicated for treatment of adults and pediatric patients with: Malignant Diseases : malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemia…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION During or immediately after FRINDOVYX administration, administer adequate amounts of fluid to reduce the risk of urinary tract toxicity ( 2.1 ). Malignant Diseases: Adult and Pediatric Patients ( 2.2 ) Intravenous: Initial course for patients with no hematologic deficiency: 40 mg/kg to 50 mg/ kg in divided doses over 2 to 5 days. Other regimens include 10 mg/kg to 15 mg/kg given every 7 to 10 days or 3 mg/kg to 5 mg/kg twice weekly. ( 2.2 ) See full prescribing information for instructions on preparation, handling, and administration. ( 2.3 ) 2.1 Important Administration Instructions During or immediately after the administration of FRINDOVYX, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity. Therefore, FRINDOVYX should be administered in the morning. 2.2 Recommended Dosage for Malignant Diseases Adults and Pediatric Patients Intravenous When used as the only oncolytic drug therapy, the recommended dosage for the initial course of FRINDOVYX for patients with no hematologic deficiency is 40 mg/kg to 50 mg/kg given intravenously in divided doses over a period of 2 to 5 days. Oth…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity FRINDOVYX is contraindicated in patients who have a history of severe hypersensitivity reactions to cyclophosphamide, any of its metabolites, or to other components of the product. Anaphylactic reactions including death have been reported with cyclophosphamide. Cross-sensitivity with other alkylating agents can occur. Urinary Outflow Obstruction FRINDOVYX is contraindicated in patients with urinary outflow obstruction [see Warnings and Precautions (5.2) ]. Hypersensitivity to cyclophosphamide ( 4 ) Urinary outflow obstruction ( 4 )

Drug Interactions

7 DRUG INTERACTIONS 7.1 Effect of Other Drugs on Cyclophosphamide Exposure Protease Inhibitors Concomitant use of protease inhibitors may increase the concentration of cytotoxic metabolites and may enhance the toxicities of cyclophosphamide, including higher incidence of infections, neutropenia, and mucositis. Monitor for increased toxicities in patients receiving protease inhibitors. 7.2 Drugs that Potentiate Cyclophosphamide Toxicities Drugs or agents with similar toxicities to FRINDOVYX and can potentiate these effects are listed in Table 2. Table 2: Drugs that Potentiate Cyclophosphamide Toxicities Toxicity Drugs Increased hematotoxicity and/or immunosuppression ● ACE inhibitors: ACE inhibitors can cause leukopenia. ● Natalizumab ● Paclitaxel: Increased hematotoxicity has been reported when cyclophosphamide was administered after paclitaxel infusion. ● Thiazide diuretics ● Zidovudine Increased cardiotoxicity ● Anthracyclines ● Cytarabine ● Pentostatin ● Radiation therapy of the cardiac region ● Trastuzumab Increased pulmonary toxicity ● Amiodarone ● G-CSF, GM-CSF (granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor) Increased nephrotoxicity ●…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. Hypersensitivity [see Contraindications (4) ] Myelosuppression, Immunosuppression, Bone Marrow Failure, and Infections [see Warnings and Precautions (5.1) ] Urinary Tract and Renal Toxicity [see Warnings and Precautions (5.2) ] Cardiotoxicity [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Secondary Malignancies [see Warnings and Precautions (5.5) ] Veno-occlusive Liver Disease [see Warnings and Precautions (5.6) ] Alcohol Content [see Warnings and Precautions (5.7) ] Infertility [see Warnings and Precautions (5.9) and Use in Specific Populations (8.3 and 8.4) ] Impaired Wound Healing [see Warnings and Precautions (5.10)] Hyponatremia [see Warnings and Precautions (5.11) ] Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials and Postmarketing Experience The following adverse reactions asso…

Frequently Asked Questions

What is Frindovyx used for?

Frindovyx contains Cyclophosphamide. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Frindovyx a controlled substance?

Frindovyx is not classified as a controlled substance by the DEA.

What is the generic name for Frindovyx?

The generic name for Frindovyx is Cyclophosphamide. There are 11 other brand versions of Cyclophosphamide.

What is the NDC code for Frindovyx 500 mg/mL?

The NDC (National Drug Code) for Frindovyx 500 mg/mL is 83831-119, listed by Avyxa Pharma, LLC.

Product NDC

83831-119

Package NDC

83831-119-01

Other Cyclophosphamide Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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