FRINDOVYX (cyclophosphamide)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Dehydration
Lactation
Urinary tract obstruction

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Cardiomyopathy
Hemorrhagic cystitis
Infection
Neutropenic disorder
Opportunistic viral infection
Pregnancy
Thrombocytopenic disorder

There are 8 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Child-pugh class C hepatic impairment
Disease of liver
Hyponatremia
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Leukopenia
Myeloproliferative neoplasm
Radiation therapy

There are 81 severe adverse reactions.

More Frequent	Less Frequent
Immunosuppression Infection Leukopenia Neutropenic disorder	Anemia Edema Hemorrhagic cystitis Jaundice Nephrotoxicity SIADH syndrome Thrombocytopenic disorder Tumor lysis syndrome

Rare/Very Rare

Abnormal hepatic function tests Acute leukemia Acute myocardial infarction Acute pancreatitis Acute pericarditis Altered mental status Anaphylaxis Angioedema Arthralgia Atrial fibrillation Atrial flutter Bronchospastic pulmonary disease Cholestasis Colitis Cystitis Disseminated intravascular coagulation Dyspnea Encephalopathy Erythema multiforme Facial edema Gastroenteritis Gastrointestinal hemorrhage Hearing loss Heart failure Hemolytic uremic syndrome Hemorrhage of myocardium Hepatic failure Hepatic veno-occlusive disease Hepatitis Hepatomegaly Hyperglycemia Hypersensitivity drug reaction Hypertension Hypoglycemic disorder Hyponatremia Hypotension Impaired wound healing Infertility Injection site sequelae Interstitial lung disease Interstitial pneumonitis Malignant lymphoma Malignant tumor of urinary bladder Myelodysplastic syndrome Myocarditis Nephrogenic diabetes insipidus Palmar-plantar erythrodysesthesia Pericardial effusion Pericardial tamponade Peripheral ischemia Posterior reversible encephalopathy syndrome Pulmonary fibrosis Pulmonary hypertension Pulmonary thromboembolism Pulmonary veno-occlusive disease Radiation recall syndrome Renal failure Rhabdomyolysis Scleroderma Seizure disorder Skin rash Stevens-johnson syndrome Stomatitis Supraventricular arrhythmias Thyroid carcinoma Toxic epidermal necrolysis Urticaria Venous thrombosis Ventricular arrhythmias

There are 41 less severe adverse reactions.

More Frequent	Less Frequent
Alopecia Anorexia Diarrhea Fever Irregular menstrual periods Nail discoloration Nausea Skin pigmentation enhancement Vomiting	Acute abdominal pain Amenorrhea Azoospermia Chills Dizziness Fatigue Flushing Headache disorder Hyperhidrosis Malaise Oligospermia

Rare/Very Rare
Acute cognitive impairment Atopic dermatitis Blistering skin Body fluid retention Conjunctivitis Constipation Dysesthesia Dysgeusia Eye tearing Muscle spasm Myalgia Nail disorders Pain in oropharynx Parosmia Parotitis Peripheral neuropathy Polyneuropathy Rhinorrhea Tinnitus Tremor Vision impairment

Cyclophosphamide can cause fetal toxicity when administered to pregnant women, but potential benefits from use of the drug may be acceptable in certain conditions despite the possible risks to the fetus. Abnormalities, including ectrodactylia, have occurred in infants born to women treated with the drug during pregnancy. Normal infants also have been born to women who received cyclophosphamide, including during the first trimester.

Cyclophosphamide should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective. When the drug is administered during pregnancy or if the patient becomes pregnant while receiving cyclophosphamide, the patient should be informed of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Cyclophosphamide is distributed into milk. Because of the potential for serious adverse reactions to cyclophosphamide in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced Geriatric Use information available for this drug.