Darolutamide (Nubeqa®)
Pronounce: dar-oh-loo-ta-mide
Classification: Anti-androgen
About Darolutamide (Nubeqa®)
Most prostate cancers need the male hormone testosterone to grow. Testosterone is an androgen (type of hormone) made by the testes and adrenal glands. Darolutamide is an anti-androgen medication. Anti-androgen therapies work by blocking an enzyme needed for the production of testosterone. Without testosterone, the cancer cells either grow more slowly or stop growing altogether.
How to Take This Medication
Darolutamide comes in tablet form, to be taken with food. The dose and how often you take this medication will be decided by your healthcare provider. Swallow the tablets whole. Do not crush or chew them. If you miss a dose of darolutamide, take your prescribed dose as soon as you remember before the next scheduled dose. Do not take 2 doses at once to make up for a missed dose.
It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.
Certain medications and supplements, including but not limited to carbamazepine, conivaptan, indinavir, itraconazole, ketoconazole, phenytoin, posaconazole, rifampin, ritonavir, St. John’s wort and telithromycin, can interfere with how darolutamide works, so be sure to tell your healthcare team about all medications, vitamins and supplements you are taking.
If you have not had a bilateral orchiectomy (removal of both testicles), this medication should be given with a gonadotropin-releasing hormone analog like leuprolide (Lupron®), gosarelin (Zoladex®) or triptorelin (Trelstar®).”
Storage and Handling
Store your medication in the original container with the label. If you want to use a pillbox, talk to your pharmacist. Keep it in a dry place at room temperature unless your provider or pharmacist tells you otherwise. Keep containers out of reach of children and pets.
If a caregiver prepares your dose for you, they should consider wearing gloves or pour the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing people should not prepare the dose for you. Ask your provider where to return any unused medication for disposal. Do not flush down the toilet or throw in the trash.
Where Do I Get This Medication?
Some cancer medications are only available through specialty pharmacies. Your provider or pharmacist will start this process. Your insurance plan may also affect where you can get your medication. Call your prescription plan provider to find out which specialty pharmacies are in-network.
Insurance Information
This medication may be covered by your prescription plan. If you qualify, you may be able to get financial help through patient assistance programs (PAP). Co-pay cards may also be available to lower your out-of-pocket cost if you have commercial (not Medicare/Medicaid/Tricare) insurance. Your pharmacist, social worker, or navigator can help find resources for financial support.
Possible Side Effects
These are some of the most common or most serious side effects of this medication. Talk with your provider about the side effects you are having and how they can be managed.
Liver Toxicity
This medication can cause liver toxicity, or liver problems, which your provider may monitor for with blood tests called liver function tests. Symptoms may be:
- Yellowing of your skin or eyes.
- Dark or brown urine.
- Pain in your abdomen (belly).
Tell your provider if you have any of these symptoms.
Low White Blood Cell Count (Leukopenia or Neutropenia)
White blood cells (WBC) help your body fight infection. While you are having treatment for cancer, your WBC count can drop, putting you at a higher risk of an infection. Tell your provider right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.
Tips for preventing infection:
- Hand washing: both yours and your visitors is the best way to prevent the spread of infection.
- Avoid large crowds and people who are sick (those who have a cold, fever, or cough, or live with someone with these symptoms).
- When working outside, wear clothes that protect you, like long pants and gloves.
- Do not handle pet waste.
- Keep all cuts and scratches clean.
- Shower or bathe daily.
- Brush your teeth at least twice a day.
- Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
- Ask your providers before scheduling dental appointments or procedures.
- Ask your providers before you or someone you live with has any vaccines.
Fatigue
Fatigue can cause exhaustion, feeling worn out and that your body is "heavy" and hard to move, or being unable to focus. It is common when you have cancer, and it is not the same as feeling tired. You may need to adjust your schedule to manage fatigue. Plan times to rest during the day and save your energy for more important activities. Exercise can help lessen fatigue. Talk to your providers about ways to deal with this side effect.
Sexual and Reproductive Changes
There is a higher risk of health problems for your baby if get someone pregnant while on this medication. To lower the risk of birth defects, you should use birth control (contraception) to avoid pregnancy.
Talk with your provider about what kind of birth control is safest for you and your partner.
If you can get someone pregnant, you will need to use effective birth control during treatment and for 1 week after the last dose of this medication, even if you believe you are not producing sperm.
Fertility
This medication may affect your reproductive system, causing changes to sperm. You may be unable to get or keep an erection. Your desire for sex may decrease during treatment. You may want to consider sperm banking if you might wish to have a child in the future. Talk about your options with your provider before treatment.
Important but Less Common Side Effects
Seizures
A seizure is caused by abnormal electrical activity in the brain and can lead to uncontrollable shaking of the body, loss of consciousness, and convulsions. The length and severity of the seizure may vary. If you are experiencing a seizure have someone call 911.
Ischemic Heart Disease
When blood flow to your heart is slowed down, it is called ischemia. This slowdown of blood can happen when your arteries are blocked or thinner than normal. Ischemic heart disease can cause chest pain and discomfort. Your provider will monitor your heart during and after treatment. Call 911 if you have chest pain that goes down your arm, jaw, or back.