Ninlaro

Ninlaro is a prescription medication used to treat multiple myeloma, a form of blood cancer, who have received at least one prior therapy.

It belongs to a group of drugs called proteasome inhibitors. These medications work by inhibiting the function of proteasomes, cellular complexes required to break down damaged or unneeded proteins inside cells, including cancer cells. The buildup of proteins causes cells to die, potentially slowing the progression of cancer.

Ninlaro is a prescription medication used to treat multiple myeloma, a form of blood cancer, who have received at least one prior therapy.

It has been approved to be used with another FDA-approved treatment for multiple myeloma called Revlimid (lenalidomide) and dexamethasone (a type of corticosteroid).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Serious side effects have been reported with Ninlaro. See "Ninlaro Precautions" section.

Common side effects of Ninlaro include:

• diarrhea
• constipation
• low blood platelet count (thrombocytopenia)
• peripheral neuropathy (numbness and pain from nerve damage, usually in the hands and feet)
• nausea
• peripheral edema (fluid under the skin causing swelling)
• vomiting
• back pain

These are not all the possible side effects of Ninlaro. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA­-1088. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• strong CYP3A inducers such as rifampin, phenytoin, carbamazepine, and St. John’s Wort.

​This is not a complete list of Ninlaro drug interactions. Ask your doctor or pharmacist for more information.

Ninlaro may cause serious side effects, including:

• Low platelet counts (thrombocytopenia). Low platelet counts are common with Ninlaro, and can sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.
• Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with Ninlaro, and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with Ninlaro. Your healthcare provider may prescribe medicine to help treat your symptoms.
• Nerve problems. Nerve problems are common with Ninlaro and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms, including:
  • tingling
  • numbness
  • pain
  • a burning feeling in your feet or hands
  • weakness in your arms or legs
• Swelling. Swelling is common with Ninlaro and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.
• Skin reactions. Tell your healthcare provider if you get a new or worsening rash.
• Liver problems. Tell your healthcare provider if you get these signs of a liver problem:
  • yellowing of your skin or the whites of your eyes
  • pain in your right upper stomach-area Back pain is also common with Ninlaro.

These are not all the possible side effects of Ninlaro. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Ninlaro, there are no specific foods you must exclude from your diet while taking this medication.

Before taking Ninlaro, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have kidney problems or are on dialysis
• are pregnant or plan to become pregnant. Ninlaro can harm your unborn baby. Avoid becoming pregnant during treatment with Ninlaro. Females who are able to become pregnant must use effective birth control during treatment and for 90 days after your final dose of Ninlaro. Males with a female partner who is able to become pregnant must use effective birth control during treatment and for 90 days after your final dose of Ninlaro. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you or your partner become pregnant while you are receiving Ninlaro. 
• are breastfeeding or plan to breastfeed. It is not known if Ninlaro passes into breast milk. Do not breastfeed during treatment with Ninlaro.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Talk to your healthcare provider before starting any new medicines during treatment with Ninlaro.

Ninlaro can cause harm to the unborn baby when administered to a pregnant woman. There are no human data available regarding the potential effect of Ninlaro on pregnancy or development of the embryo or fetus. Ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose.

• Tell your healthcare provider if you are pregnant or plan to become pregnant. Ninlaro can harm your unborn baby.
• Avoid becoming pregnant during treatment with Ninlaro.
• Females who are able to become pregnant must use effective birth control during treatment and for 90 days after your final dose of Ninlaro.
• Males with a female partner who is able to become pregnant must use effective birth control during treatment and for 90 days after your final dose of Ninlaro.
• Talk to your healthcare provider about birth control methods that may be right for you.
• Tell your healthcare provider right away if you or your partner become pregnant while you are receiving Ninlaro.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Ninlaro passes into breast milk. Do not breastfeed during treatment with Ninlaro.

• Take Ninlaro exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Ninlaro without talking to your healthcare provider first.
• Ninlaro is taken in “cycles.” Each cycle lasts 4 weeks (28 days).
  • The usual dose of Ninlaro is 1 capsule taken 1 time each week, on the same day of the week for the first 3 weeks of each cycle.
  • Take each dose of Ninlaro at about the same time of day.
  • Take Revlimid (lenalidomide) and dexamethasone exactly as your healthcare provider tells you to.
  • Your healthcare provider will do blood tests during treatment with Ninlaro to check for side effects.
  • Your healthcare provider may change your dose or stop Ninlaro, Revlimid (lenalidomide), or dexamethasone if you have side effects.
• Take Ninlaro at least 1 hour before or at least 2 hours after food.
• On the days that you take both Ninlaro and dexamethasone, do not take Ninlaro and dexamethasone at the same time. Take dexamethasone with food.
• Swallow Ninlaro capsules whole with water. Do not crush, chew or open the capsule.
• Avoid direct contact with the capsule contents. If you accidentally get powder from the Ninlaro capsule on your skin, wash the area well with soap and water. If you accidentally get powder from the Ninlaro capsule in your eyes, flush your eyes well with water.
• If you miss a dose of Ninlaro, or if you are late taking a dose, take the dose as long as the next scheduled dose is more than 3 days (72 hours) away. Do not take a missed dose of Ninlaro if it is within 3 days (72 hours) of your next scheduled dose.

If you vomit after taking a dose of Ninlaro, do not repeat the dose. Take your next dose of Ninlaro on the next scheduled day and time.

If you take more Ninlaro than your healthcare provider tells you to take, call your healthcare provider right away or go to the nearest hospital emergency room. 

Ninlaro is dosed in combination with Revlimid (lenalidomide) and dexamethasone.

The recommended starting dose of Ninlaro is 4 mg administered orally once a week on Days 1, 8, and 15 of a 28-day treatment cycle.

The recommended starting dose of Revlimid (lenalidomide) is 25 mg administered daily on Days 1 through 21 of a 28-day treatment cycle.

The recommended starting dose of dexamethasone is 40 mg administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle. 

The dosage may be reduced with neutropenia, hepatic impairment or renal impairment.

If you take too much Ninlaro, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Ninlaro at room temperature.
• Do not store above 86°F (30°C).
• Do not freeze Ninlaro.
• Store Ninlaro capsules in the original packaging until just before each use.
• Ask your pharmacist or healthcare provider about how to dispose of (throw away) unused Ninlaro.

Keep Ninlaro and all medicines out of the reach of children.