CYCLOPHOSPHAMIDE 200 mg/mL
cyclophosphamide · INJECTION, SOLUTION · BluePoint Laboratories
CYCLOPHOSPHAMIDE is a injection, solution containing cyclophosphamide at 200 mg/mL, taken intravenous. Manufactured by BluePoint Laboratories.
Key Facts
- Brand Name
- CYCLOPHOSPHAMIDE
- Generic Name
- cyclophosphamide
- NDC Code (Product)
68001-565- Manufacturer
- BluePoint Laboratories
- Strength
- 200 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA212501
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 04/10/2023
Recall History
Infusion Options, Inc.
Lack of Assurance of Sterility
X-Gen Pharmaceuticals Inc.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Sandoz Inc
cGMP deviations: Temperature excursion during transportation.
X-Gen Pharmaceuticals Inc.
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Cyclophosphamide for injection 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, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma ( 1.1 ) Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy ( 1.2 ) Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. (1.2) 1.1 Malignant Diseases Cyclophosphamide for injection 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 (…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION During or immediately after cyclophosphamide for injection 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 per kg to 50 mg per kg in divided doses over 2 to 5 days. Other regimens include 10 mg per kg to 15 mg per kg given every 7 to 10 days or 3 mg per kg to 5 mg per kg twice weekly. Oral: 1 mg per kg per day to 5 mg per kg per day for both initial and maintenance dosing. Minimal Change Nephrotic Syndrome in Pediatric Patients ( 2.3 ) Oral: 2 mg per kg daily for 8 to 12 weeks (maximum cumulative dose 168 mg per kg). Treatment beyond 90 days increases the probability of sterility in males. ( 8.4 ) 2.1 Important Administration Instructions During or immediately after the administration of cyclophosphamide for injection, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity. Therefore, cyclophosphamide for injection should be administered in the morning. 2.2 Recommended Dosage for Malignant D…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity Cyclophosphamide for injection 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 Cyclophosphamide for injection 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 Radiation therapy or drugs with similar toxicities to cyclophosphamide for injection can potentiate toxicities for cyclophosphamide. Monitor for increased toxicities in patients receiving radiation therapy or drugs known to cause: Myelosuppression and/or immunosuppression [ see Warnings and Precautions ( 5.1 )] Nephrotoxicity including hemorrhagic cystitis [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 )] Hepatotoxicity including liver necrosis and VOD [see Warnings and Precautions ( 5.6 )] 7.3 Effect of Cyclophosphamide on Other Drugs Metronidazole Acute encephalopathy has been reported …
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 )] Infertility [ see Warnings and Precautions ( 5.8 ) and Use in Specific Populations ( 8.3 , 8.4 )] Impaired Wound Healing [see Warnings and Precautions ( 5.9 )] Hyponatremia [see Warnings and Precautions ( 5.10 )] Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials and Postmarketing Experience The following adverse reactions associated with the use of cyclop…
Frequently Asked Questions
What is CYCLOPHOSPHAMIDE used for?
CYCLOPHOSPHAMIDE contains cyclophosphamide. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is CYCLOPHOSPHAMIDE a controlled substance?
CYCLOPHOSPHAMIDE is not classified as a controlled substance by the DEA.
What is the generic name for CYCLOPHOSPHAMIDE?
The generic name for CYCLOPHOSPHAMIDE is cyclophosphamide. There are 9 other brand versions of cyclophosphamide.
What is the NDC code for CYCLOPHOSPHAMIDE 200 mg/mL?
The NDC (National Drug Code) for CYCLOPHOSPHAMIDE 200 mg/mL is 68001-565, listed by BluePoint Laboratories.
Other CYCLOPHOSPHAMIDE Dosages
Other Cyclophosphamide Brands
See all →- Cyclophosphamide500 mg/25mL83634-205
- Cyclophosphamide2 g/4mL83831-118
- Cyclophosphamide1 g/50mL0781-3244
- Cyclophosphamide25 mg/110019-982
- Cyclophosphamide50 mg/10054-0383
- Cyclophosphamide500 mg/25mL72572-087
- Frindovyx500 mg/mL83831-119
- Cyclophosphamide500 mg/5mL0781-3528
- Cyclophosphamide2000 mg/20mL0781-3530
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)