Zuviphos Tab

Zuviphos Tab

Cyclophosphamide Tab

Strength: 50mg

Pack Size: 1 x 10

Drug Class: Antineoplastic

Dosage and Administration:

Dosage Forms and Strengths

Powder for injection
50 mg

Dosage Considerations – Should be Given as Follows:

Malignant Diseases

Adult and Pediatric

Intravenous (IV) (intermittent therapy): 40-50 mg/kg (400-1800 mg/m²) divided over 2-5 days; may be repeated at intervals of 2-4 weeks
IV (continuous daily therapy): 60-120 mg/m²/day (1-2.5 mg/kg/day)
Oral (intermittent therapy): 400-1000 mg/m² divided over 4-5 days
Oral (continuous daily therapy): 50-100 mg/m²/day or 1-5 mg/kg/day
Nephrotic Syndrome

2-3 mg/kg/day for up to 12 weeks when corticosteroids unsuccessful
Non-Hodgkin Lymphoma

600-1500 mg/m² intravenously (IV) with other antineoplastics (part of CHOP regimen); dose intensification possible
Breast Cancer

600 mg/m² intravenously (IV) with other antineoplastics; dose intensification possible
Systemic Lupus Erythematosus, Pediatric

500-750 mg/m² intravenously (IV) monthly; not to exceed 1 g/m²
Juvenile Idiopathic Arthritis/Vasculitis (Off-label)

10 mg/kg intravenously (IV) every 2 weeks
Lupus Nephritis (Off-Label)

Induction therapy for lupus nephritis (American College of Rheumatology Guidelines 2012)
Low-dose: 500 mg intravenously (IV) every 2 weeks for 6 doses plus corticosteroids, then maintenance with mycophenolate mofetil or azathioprine
High-dose: 500-1000 mg/m² IV monthly for 6 doses plus corticosteroids
Dosing Modifications

Hepatic impairment: Give 75% of normal dose if transaminase levels are greater than 3 times upper limit of normal (ULN) or bilirubin is 3.1-5 mg/dL
Renal impairment: CrCl less than 10 mL/minute, give 75% of normal dose; CrCl greater than 10 mL/minute, give full dose

Cold Storage: no

Zuviphos (cyclophosphamide) is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula:

CYCLOPHOSPHAMIDE Structural Formula Illustration

Cyclophosphamide has a molecular formula of C7H15Cl2N2O2P•H2O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol.

Cyclophosphamide Tablets, USP are for oral use and contain 25 mg or 50 mg cyclophosphamide (anhydrous). Inactive ingredients in Cyclophosphamide Tablets are: acacia, FD&C Blue No. 1, D&C Yellow No. 10 Aluminum Lake, lactose, magnesium stearate, starch, stearic acid and talc.

Malignant Diseases

Cyclophosphamide is indicated for the treatment of:

  • malignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkina 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.

Minimal Change Nephrotic Syndrome In Pediatric Patients

Cyclophosphamide is indicated for the treatment of biopsy proven minimal change nephrotic syndrome in pediatrics patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy.

Limitations Of Use

The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established.

Cyclophosphamide has been demonstrated to have a cytostatic effect in many tumour types. The active metabolites of cyclophosphamide are alkylating agents which transfer alkyl groups to DNA during the process of cell division, thus preventing normal synthesis of DNA.

Cyclophosphamide is well absorbed following an oral dose with a mean half-life of 4-8 hours for both oral and parenteral administration.

It is an inactive pro drug with alkylating metabolites produced by hepatic metabolism, reaching peak levels 4-6 hours after an iv injection. Hepatic enzymes may be induced. The parent compound binds poorly to plasma protein but the active metabolites are significantly protein-bound. The drug is widely distributed and crosses the blood-brain barrier, the placental barrier and is found in ascites. The metabolites are excreted renally.

Cyclophosphamide can cause myelosuppression (leukopenianeutropeniathrombocytopenia and anemia), bone marrow failure, and severe immunosuppression which may lead to serious and sometimes fatal infections, including sepsis and septic shockLatent infections can be reactivated.Cyclophosphamide should not be administered to patients with neutrophils ≤ 1,500/mm³ and platelets < 50,000/mm³. Cyclophosphamide treatment may not be indicated, or should be interrupted, or the dose reduced, in patients who have or who develop a serious infection.Cyclophosphamide should be used with caution, if at all, in patients with active urinary tract infections.

Inform patients of the possibility of myelosuppression, immunosuppression, and infections. Explain the need for routine blood cell counts. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever

Advise the patient to report urinary symptoms (patients should report if their urine has turned a pink or red color) and the need for increasing fluid intake and frequent voiding

Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness

Warn patients of the possibility of developing non-infectious pneumonitis. Advise patients to report promptly any new or worsening respiratory symptoms