custirsen

Custirsen is an investigational medication being studied for use as a second-line treatment of metastatic castration-resistant prostate cancer and advanced or metastatic non-small cell lung cancer, to improve overall survival. Custirsen is administered as an intravenous injection, and has been used in combination with anticancer (antineoplastic) chemotherapy drugs including docetaxel or cabazitaxel in clinical trials. Custirsen is yet to receive approval from the FDA.

Custirsen belongs to a class of medications known as antisense oligonucleotides (ASOs). ASOs are short single-stranded DNA molecules that can alter the RNA of specific genes to modify protein production. Custirsen works by inhibiting the production of clusterin, a chaperone protein that protects cells from programmed death (apoptosis) in stressful conditions. Clusterin, which has been found to be overexpressed in many types of cancers, protects cancer cells from apoptosis and makes them treatment-resistant.

Warning

• Custirsen is yet to be approved by the FDA and there is no information on the contraindications and warnings pertaining to custirsen.

Common side effects of custirsen include:

• Blood disorders including:
  • Low neutrophil immune cells (neutropenia)
  • Low red blood cell count (anemia)
  • Low count of platelets (thrombocytopenia)
  • Low count of leukocyte immune cells (leukopenia)
• Diarrhea
• Loss of appetite
• Fever
• Chills
• Fatigue
• Hair loss

Side effects of custirsen used in combination with docetaxel

• Fluid around the lungs (pleural effusion)
• Shortness of breath (dyspnea)
• Inflammation of mucous membranes in the gastrointestinal tract

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Custirsen is yet to be approved by the FDA and at present, there are no established recommended dosages. In clinical trials, maximum decrease of blood plasma of clusterin was observed at 640 mg of intravenous infusion of custirsen.

Overdose

There is no information available on custirsen overdose.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

Custirsen is an investigational drug. No information is available regarding drug interactions of custirsen.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

Custirsen is in clinical trials. There is no information available on the use of custirsen in pregnant or breastfeeding women.