What is Ninlaro?

Ninlaro Dosage, forms & strengths

Medically reviewed by Jamie Winn, PharmD

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Ninlaro (ixazomib) is an oral medication for cancer that is manufactured by Takeda Pharmaceuticals Inc. It is FDA-approved as part of a combination of medications used to treat adults with relapsed or refractory multiple myeloma. It is not approved to treat pediatric patients under 18 years of age.

What is Ninlaro’s mechanism of action?

Ixazomib is a reversible proteasome inhibitor that targets certain proteins in multiple myeloma cells to stop the growth and spread of multiple myeloma in adults who have failed at least 1 prior therapy.

Ninlaro dosage forms and strengths

2.3 mg capsule (light pink capsule with the logo on the cap and 2.3mg on the body in black ink)
3 mg capsule (light gray capsule with the logo on the cap and 3mg on the body in black ink)
4 mg capsule (light orange capsule with the logo on the cap and 4mg on the body in black ink)

Ninlaro dosage

Dosing schedule for Ninlaro along with lenalidomide and dexamethasone:

The recommended dose of Ninlaro is 4mg by mouth once a week on Days 1, 8, and 15 of a 28-day treatment cycle.
The recommended dose of Revlimid (lenalidomide) is 25mg by mouth daily on Days 1 through 21 of a 28-day treatment cycle.
The recommended dose of Decadron (dexamethasone) is 40mg daily on Days 1, 8, 15, and 22 of a 28-day treatment cycle.

Ninlaro dosage restrictions

The starting dose of Ninlaro should be reduced to 3mg in patients with moderate or severe hepatic impairment.
The starting dose of Ninlaro should be reduced to 3mg in patients with severe renal impairment or end-stage renal disease (ESRD) requiring dialysis.
You may also need a dose modification or dose reduction based on your platelet count, absolute neutrophil count, or if you have non-hematologic toxicities such as rash or peripheral neuropathy. Please see the package insert for additional information.

How to take Ninlaro

Read the Full Prescribing Information and Medication Guide that comes with this medication.
Take this medication exactly as your healthcare provider tells you to. Do not change your dose or stop taking Ninlaro without talking with them first.
The usual dose of Ninlaro is 1 capsule by mouth once weekly on the same day of the week for 3 weeks of a 4-week cycle. You should take Ninlaro 1 hour before or 2 hours after food. You will also take Revlimid (lenalidomide) and Decadron (dexamethasone) along with Ninlaro. Dexamethasone should be taken with food.
Ninlaro capsules should be swallowed whole with water. You should avoid direct contact with the capsule contents. If you come into contact with the contents, wash the affected area with soap and water.
If you miss a dose of Ninlaro, take it when you remember as long as your next scheduled dose is more than 3 days (72 hours) away. If your next dose is less than 3 days away, skip the missed dose and resume your treatment at the time of the next scheduled dose.
If you vomit after a dose of Ninlaro, do not retake it until your next scheduled dose.
If you think you have taken more Ninlaro than prescribed, call your doctor right away or go to the nearest emergency room because overdosage has led to deaths.
Store Ninlaro capsules at room temperature between 59° to 86°F (15°C to 30°C) in the original blister pack until you are ready to use them.

Ninlaro dosage FAQs

What are some side effects of Ninlaro?

Some common adverse events of Ninlaro seen in clinical trials include:

Gastrointestinal toxicities such as diarrhea, constipation, nausea, and vomiting
Peripheral edema (swelling of your feet or hands)
Peripheral neuropathy (numbness, tingling, or pain in your hands and feet)
Back pain
Conjunctivitis (pink eye)
Dry eyes
Upper respiratory tract infection
Shingles

Ninlaro can sometimes cause more serious adverse reactions, including:

Serious hypersensitivity reactions (hives, swelling of your face or throat, and shortness of breath)
Low platelet counts (thrombocytopenia)
Low white blood cell count (neutropenia)
Thrombotic microangiopathy (blood clots in small blood vessels), including thrombotic thrombocytopenic purpura
Hepatotoxicity or other liver problems such as elevated liver enzymes
New or worsening skin rash or cutaneous reactions including Stevens-Johnson syndrome

Contact your healthcare professional for medical advice about any adverse reactions you experience while taking Ninlaro. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are some drug interactions with Ninlaro?

The concomitant use of Ninlaro with other drugs can change how they work or increase the frequency and severity of side effects. You should ask your healthcare professional if any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication, including:

Moderate to strong CYP3A inducers such as phenytoin, carbamazepine, and St. John’s wort

Are there any contraindications for Ninlaro?

Ninlaro is contraindicated if you have a known hypersensitivity to ixazomib citrate or any inactive ingredients in this product.

Is it safe to use Ninlaro while pregnant or breastfeeding?

Ninlaro should not be used by pregnant women as it may harm their unborn baby. You should take a pregnancy test before beginning Ninlaro treatment. Females who may become pregnant should use effective non-hormonal contraceptives during treatment and for 90 days after their last dose. Males who have female partners should also use a barrier method of contraception during Ninlaro treatment and for 90 days after their last dose. It is not known if Ninlaro is found in breast milk during lactation or what effects it may have on a breastfed infant. You should not breastfeed during Ninlaro treatment 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 effective is Ninlaro?

According to the package insert, one study compared a group taking Ninlaro, lenalidomide, and dexamethasone to a group taking a placebo along with lenalidomide and dexamethasone. The average progression-free survival (PFS) was 20 months in the Ninlaro regimen and 15.9 months in the placebo regimen.

How long do you take Ninlaro?

Ninlaro is an oral medication that is taken once a week on the same day of the week for 3 weeks of a 4-week cycle. It is taken along with Decadron (dexamethasone) and Revlimid (lenalidomide) until you have disease progression or unacceptable toxicity.

Does Ninlaro cause shingles?

No, Ninlaro does not cause shingles (herpes zoster). If you have had chickenpox before, taking Ninlaro will increase your risk of reactivating the virus, causing an outbreak of shingles. Your doctor may consider antiviral prophylaxis to help reduce this risk of herpes zoster reactivation.

How does Ninlaro affect your platelets?

When taking Ninlaro, your platelets typically hit their lowest point between Days 14-21 of each 28-day cycle and recover to their baseline by the start of the next cycle. Your doctor may recommend discontinuation of therapy or platelet transfusions based on standard medical guidelines if your platelets remain low.

What is the average price of Ninlaro?

There is no generic for Ninlaro and it is extremely expensive. The average cost of #3 Ninlaro 3mg capsules is over $13,000.

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The content on this website is intended for information purposes only. It does not constitute medical advice. The information on this website should not be relied upon and is not a substitute for professional medical advice. You should always speak to your doctor regarding the risks and benefits of any treatment.