Cyclophosphamide oral and injection

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blood in your urine or stools, pain or burning when you urinate;

• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

• sudden chest pain or discomfort, wheezing, dry cough or hack, feeling short of breath on exertion;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• extreme thirst with headache, vomiting, and weakness;

• jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, loss of appetite, stomach pain or upset, diarrhea;

• temporary hair loss;

• a wound that will not heal;

• missed menstrual periods;

• changes in skin color; or

• changes in nails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all medications you use, and those you start or stop using during your treatment with cyclophosphamide, especially:

• phenobarbital (Solfoton); or

• drugs that weaken the immune system such as medicines to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders.

This list is not complete. Other drugs may interact with cyclophosphamide, including prescription, over-the-counter, vitamin, and herbal products. Not all possible interactions are listed in this medication guide.

For use in the treatment of epithelial ovarian cancer:

600 mg/m2 intravenously on day one in combination with carboplatin or cisplatin
Repeat cycle every 28 days.

When use for biopsy proven "minimal change" nephrotic syndrome in children, a dose of 2.5 to 3 mg/kg/day orally for 60 to 90 days is recommended.

Cyclophosphamide has been found in human milk up to 6 hours after a single 500 mg IV dose. Absolute neutropenia has been described in a nursing infant whose mother received 800 mg of cyclophosphamide, along with vincristine and prednisone therapy. Neutropenia and thrombocytopenia were observed in another nursing infant whose mother received 6 mg/kg/day of cyclophosphamide IV. After the third dose, the nursing infants leukocyte an platelet counts fell from pretreatment values of 4,800/mm3 and 270,000/mm3 to 3,200/mm3 and 47,000/mm3, respectively.

Cyclophosphamide is excreted into human milk. Neutropenia, thrombocytopenia, and immune suppression have been observed in infants whose mothers were receiving this drug during lactation. The drug also has an unacceptable risk of carcinogenesis. The American Academy of Pediatrics considers the use of cyclophosphamide to be contraindicated during breast-feeding.

Summary of Use during Lactation

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially alkylating agents such as cyclophosphamide.[1] Neutropenia has been reported in 2 infants whose mothers breastfed them while receiving cyclophosphamide. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.[2] Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

Drug Levels

Maternal Levels.Unmetabolized cyclophosphamide was qualitatively detected in milk 1, 3, 5 and 6 hours after IV injection of 500 mg of drug in one patient.[2][3] Quantitative determination has not been reported.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In one 23-day-old infant, neutropenia, thrombocytopenia and a low hemoglobin were possibly caused by cyclophosphamide after 3 days of maternal treatment with cyclophosphamide 6 mg/kg IV daily (total dose 300 mg).[4]

In a 4-month-old, neutropenia was probably caused by cyclophosphamide in a mother 9 days after the last of 6 weekly doses of 800 mg cyclophosphamide intravenously, 2 mg vincristine intravenously and daily doses of 30 mg of prednisolone orally. Neutropenia persisted at least 12 days and was accompanied by a brief episode of diarrhea.[5]

Effects on Lactation and Breastmilk

Telephone follow-up study was conducted on 74 women who received cancer chemotherapy at one center during the second or third trimester of pregnancy to determine if they were successful at breastfeeding postpartum. Only 34% of the women were able to exclusively breastfeed their infants, and 66% of the women reported experiencing breastfeeding difficulties. This was in comparison to a 91% breastfeeding success rate in 22 other mothers diagnosed during pregnancy, but not treated with chemotherapy. Other statistically significant correlations included: 1. mothers with breastfeeding difficulties had an average of 5.5 cycles of chemotherapy compared with 3.8 cycles among mothers who had no difficulties; and 2. mothers with breastfeeding difficulties received their first cycle of chemotherapy on average 3.4 weeks earlier in pregnancy. Of the 56 women who received a cyclophosphamide-containing regimen, 34 had breastfeeding difficulties.[7]

References

1. Pistilli B, Bellettini G, Giovannetti E et al. Chemotherapy, targeted agents, antiemetics and growth-factors in human milk: How should we counsel cancer patients about breastfeeding? Cancer Treat Rev. 2013;39:207-11. PMID: 23199900

2. Urbaniak C, McMillan A, Angelini M et al. Effect of chemotherapy on the microbiota and metabolome of human milk, a case report. Microbiome. 2014;2:24. PMID: 25061513

3. Duncan JH, Colvin OM, Fenselau C. Mass spectrometric study of the distribution of cyclophosphamide in humans. Toxicol Appl Pharmacol. 1973;24:317-23. PMID: 4741053

4. Wiernik PH, Duncan JH. Cyclophosphamide in human milk. Lancet. 1971;1(7705):912. PMID: 4102054

5. Durodola JI. Administration of cyclophosphamide during late pregnancy and early lactation: a case report. J Nat Med Assoc. 1979;71:165-6. PMID: 423292

6. Amato D, Niblett JS. Neutropenia from cyclophosphamide in breast milk. Med J Aust. 1977;1:383-4. PMID: 859486

7. Stopenski S, Aslam A, Zhang X et al. After chemotherapy treatment for maternal cancer during pregnancy, is breastfeeding possible? Breastfeed Med. 2017;12:91-7. PMID: 28170295

LactMed Record Number

77

Last Revision Date

20170411

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.