What is Ninlaro Uses, warnings & interactions
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Ninlaro (ixazomib) is an oral cancer medication that is manufactured by Takeda Pharmaceuticals Inc. It was approved by the U.S. Food and Drug Administration (FDA) in 2015 as a part of a combination therapy that increases progression-free survival (PFS) in patients with multiple myeloma. It is typically used in patients who have relapsed or refractory multiple myeloma.
If your doctor has prescribed Ninlaro to you, you may want to know more about what it is and how it works. Here we’ll explain what Ninlaro is used for, how it works, its side effects, and more.
What is Ninlaro used for?
Ninlaro is used along with Revlimid (lenalidomide) and Decadron (dexamethasone) to treat patients with multiple myeloma who have tried at least one prior therapy. Ninlaro should not be used in patients receiving maintenance treatment or who are newly diagnosed unless they are part of a controlled clinical study.
How does Ninlaro work?
Ninlaro is a reversible proteasome inhibitor that causes the death of multiple myeloma cells in patients who relapsed after prior therapies.
What are the most commonly prescribed doses of Ninlaro?
- 2.3mg capsule
- 3mg capsule
- 4mg capsule
Before taking Ninlaro
Before taking Ninlaro, tell your healthcare provider about your medical conditions, including:
- Liver problems
- Renal (kidney) problems or are on dialysis
- Are pregnant, plan on becoming pregnant, or are breastfeeding
How to take Ninlaro
- Read the Full Prescribing Information and Medication Guide that comes with Ninlaro.
- Take Ninlaro exactly as your doctor prescribes it. Do not change your dose or stop taking this medication without discussing it with them first.
- The usual dose of Ninlaro is 1 capsule taken by mouth once a week on the same day of the week for 3 weeks of a 4-week cycle. Ninlaro should be taken 1 hour before or 2 hours after you eat. Your doctor will also prescribe Revlimid (lenalidomide) and Decadron (dexamethasone) to take along with Ninlaro. Dexamethasone should be taken with food.
- Ninlaro capsules should be swallowed whole with water. You should not come into direct contact with the contents of the capsule. If you come into contact with the powder inside the capsule, wash the affected area with soap and water.
- You can take any missed dose of Ninlaro immediately if your next scheduled dose is more than 3 days away. If it is less than 3 days until your next dose, skip the missed dose and take it on the next scheduled day.
- If you vomit after a dose of this medication, do not retake it until your next scheduled day.
- If you think you have taken more Ninlaro than prescribed, call your doctor right away or go to the nearest emergency room.
- Store Ninlaro capsules at room temperature between 59° to 86°F (15°C to 30°C) in the original packaging until you are ready to use them.
You should not use Ninlaro if you have a known allergy to ixazomib or any inactive ingredients in its formulation.
- Ninlaro can cause thrombocytopenia (low platelets) so you should have your platelet counts checked at least once a month during treatment.
- You may need your dose adjusted if you develop severe GI toxicities such as diarrhea, constipation, nausea, and vomiting.
- This medication can cause nerve problems. Notify your doctor if you develop new or worsening numbness, pain, or tingling in your hands and feet.
- You should be monitored for fluid retention. Notify your doctor if you experience swelling in your hands and feet or have sudden, unexplained weight gain.
- You should have your liver enzymes monitored during Ninlaro treatment as this medication can cause liver toxicity.
- Ninlaro can cause serious and sometimes fatal blood clots in the small blood vessels of your major organs. Find immediate medical attention if you have symptoms such as fever, bruising, nosebleeds, unusual fatigue, or decreased urination.
- Ninlaro can cause skin reactions and rashes that can sometimes be fatal. Tell your doctor immediately if you develop a new or worsening rash, blistering or peeling of your skin, or sores in your mouth.
What drugs should not be taken with Ninlaro?
When Ninlaro is taken with other medications, it may change how they work or increase the frequency and severity of side effects. You should ask your doctor if any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may cause drug interactions with Ninlaro, including:
- Moderate to strong CYP3A inducers such as phenytoin, carbamazepine, and St. John’s wort
What are some possible side effects of Ninlaro?
The most common side effects of Ninlaro seen in clinical trials include:
- Peripheral edema (swelling of your feet or hands)
- Peripheral neuropathy (pain, numbness, or tingling in your hands and feet)
- Back pain
- Blurred vision
- Dry eyes
- Upper respiratory tract infection
- Herpes zoster (shingles)
Ninlaro can sometimes cause more serious side effects, including:
- Serious hypersensitivity reactions (hives, swelling of your face or throat, and shortness of breath)
- Low platelet counts
- Low white blood cell count
- Thrombotic microangiopathy, which causes blood clots and damages small blood vessels in your organs
- Liver problems including jaundice (yellowing of your skin and eyes)
- Skin rash and skin reactions including Stevens-Johnson syndrome
Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Ninlaro. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Your doctor can prescribe other medications if Ninlaro is not right for you. Some alternative FDA-approved options include:
- Kyprolis (carfilzomib)
- Velcade (bortezomib)
- Tarceva (erlotinib)
- Lynparza (olaparib)
- Xtandi (enzalutamide)
Can you take Ninlaro while you are pregnant or breastfeeding?
Ninlaro should not be used during pregnancy as it may cause fetal harm. You should take a pregnancy test before starting treatment with this medication. Females who can become pregnant should use an effective non-hormonal contraceptive during Ninlaro treatment and for 90 days after their last dose. Males who have female partners that can become pregnant should also use effective birth control during treatment and for 90 days after their last dose. It is not known if Ninlaro is found in breast milk or what effects it may have on a breastfed infant. You should not breastfeed during treatment with Ninlaro and for 90 days after your last dose. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
How long can you take Ninlaro?
Ninlaro can be taken long-term until your disease worsens or until you can no longer tolerate this medication.
How long does it take Ninlaro to work?
According to the manufacturer, clinical trials showed that the average time that it took patients to respond was 1 month with Ninlaro, Revlimid (lenalidomide), and Decadron (dexamethasone) versus 2 months in patients taking a placebo.
Is Ninlaro a type of chemotherapy?
No, Ninlaro is not a form of chemotherapy. Ninlaro is a targeted therapy that works on certain proteins in cancer cells.
How much does Ninlaro cost?
Currently, there is no generic Ninlaro available on the market. The average cost of #3 Ninlaro 3mg capsules is over $13,000. However, you can save on brand-name drugs like Ninlaro through NiceRx if eligible for assistance.