"The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Hexalen Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Hexalen (altretamine) is used to treat cancer of the ovaries. It is a cancer (antineoplastic) medication. Common side effects include nausea/vomiting (may be severe), or loss of appetite.
Doses of Hexalen are calculated on the basis of body surface area. Hexalen may be administered either for 14 or 21 consecutive days in a 28-day cycle at a dose of 260 mg/mē/day. The total daily dose should be given as 4 divided oral doses after meals and at bedtime. Hexalen may interact with monoamine oxidase inhibitors (MAOIs), cimetidine, or "live" vaccines. Tell your doctor all medications and supplements you use, and all vaccines you have recently received. Hexalen is not recommended for use during pregnancy. It may harm a fetus. Consult your doctor to discuss using at least 2 forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.
Our Hexalen (altretamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Hexalen in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
- decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
- pain, tremors, tingling, burning, or prickling in hands or feet;
- mood changes;
- severe drowsiness or loss of consciousness;
- loss of coordination, weakness, dizziness, unsteadiness or falling; or
- severe nausea or vomiting.
Other less serious side effects may be more likely to occur. Talk to your doctor if you experience:
- temporary hair loss;
- itching or rash; or
- mild to moderate nausea or vomiting.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Hexalen (Altretamine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Hexalen Overview - Patient Information: Side Effects
Nausea, vomiting, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may reduce your dose or prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Temporary hair loss may rarely occur. Normal hair growth should return after treatment has ended.
Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine.
Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, dark urine, severe stomach/abdominal pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Hexalen (Altretamine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Hexalen FDA Prescribing Information: Side Effects
With continuous high-dose daily HEXALEN® (altretamine) capsules, nausea and vomiting of gradual onset occur frequently. Although in most instances these symptoms are controllable with anti-emetics, at times the severity requires HEXALEN® (altretamine) capsules dose reduction or, rarely, discontinuation of HEXALEN® (altretamine) capsules therapy. In some instances, a tolerance of these symptoms develops after several weeks of therapy. The incidence and severity of nausea and vomiting are reduced with moderate-dose administration of HEXALEN® (altretamine) capsules. In 2 clinical studies of single-agent HEXALEN® (altretamine) capsules utilizing a moderate, intermittent dose and schedule, only 1 patient (1%) discontinued HEXALEN® (altretamine) capsules due to severe nausea and vomiting.
Peripheral neuropathy and central nervous system symptoms (mood disorders, disorders of consciousness, ataxia, dizziness, vertigo) have been reported. They are more likely to occur in patients receiving continuous high-dose daily HEXALEN (altretamine) ® (altretamine) capsules than moderate-dose HEXALEN® (altretamine) capsules administered on an intermittent schedule. Neurologic toxicity has been reported to be reversible when therapy is discontinued. Data from a randomized trial of HEXALEN® (altretamine) capsules and cisplatin plus or minus pyridoxine in ovarian cancer indicated that pyridoxine significantly reduced neurotoxicity; however, it adversely affected response duration suggesting that pyridoxine should not be administered with HEXALEN® (altretamine) capsules and/or cisplatin (1).
HEXALEN® (altretamine) capsules causes mild to moderate dose-related myelosuppression. Leukopenia below 3000 WBC/mm³occurred in <15% of patients on a variety of intermittent or continuous dose regimens. Less than 1% had leukopenia below 1000 WBC/mm³. Thrombocytopenia below 50,000 platelets/mm³was seen in <10% of patients. When given in doses of 8-12 mg/kg/day over a 21 day course, nadirs of leukocyte and platelet counts were reached by 3-4 weeks, and normal counts were regained by 6 weeks. With continuous administration at doses of 6-8 mg/kg/day, nadirs are reached in 6-8 weeks (median).
Data in the following table are based on the experience of 76 patients with ovarian cancer previously treated with a cisplatin-based combination regimen who received single-agent HEXALEN® (altretamine) capsules. In one study, HEXALEN® (altretamine) capsules, 260 mg/m²/day, was administered for 14 days of a 28 day cycle. In another study, HEXALEN® (altretamine) capsules, 6-8 mg/kg/day, was administered for 21 days of a 28 day cycle.
ADVERSE EXPERIENCES IN 76 PREVIOUSLY TREATED OVARIAN CANCER
PATIENTS RECEIVING SINGLE-AGENT HEXALEN® (altretamine) CAPSULES
|Nausea and Vomiting||33|
|Mild to Moderate||32|
|Increased Alkaline Phosphatase||9|
|Peripheral Sensory Neuropathy||31|
|Moderate to Servere||9|
|Anorexia and Fatigue||1|
|Moderate to Severe||13|
|Serum Cretinine 1.6-3.75mg/dl||7|
Additional adverse reaction information is available from 13 single-agent altretamine studies (total of 1014 patients) conducted under the auspices of the National Cancer Institute. The treated patients had a variety of tumors and many were heavily pretreated with other chemotherapies; most of these trials utilized high, continuous daily doses of altretamine (612 mg/kg/day). In general, adverse reaction experiences were similar in the two trials described above. Additional toxicities, not reported in the above table, included hepatic toxicity, skin rash, pruritus and alopecia, each occurring in <1% of patients.
Read the entire FDA prescribing information for Hexalen (Altretamine)
Additional Hexalen Information
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