What is Exkivity?
Exkivity is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC):
- that has spread to other parts of the body (metastatic) and cannot be removed by surgery, and
- has a certain abnormal epidermal growth factor receptor (EGFR) gene, and
- whose disease has worsened while on or after chemotherapy that contains platinum
Your healthcare provider will perform a test to make sure that Exkivity is right for you.
It is not known if this medicine is safe and effective in children.
Exkivity may cause serious side effects, including:
- Changes in the electrical activity of your heart called QTc prolongation and Torsades de Pointes. QTc prolongation can cause irregular heartbeats that can be life-threatening and may lead to death. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) and do blood tests to check your electrolytes before starting, and during treatment. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint or have an irregular heartbeat.
See Exkivity side effects for more information about side effects.
Before taking Exkivity
Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems, including a condition called long QTc syndrome
- have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
- have lung or breathing problems other than lung cancer
- are pregnant or plan to become pregnant. Exkivity can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment.
- You should use an effective form of non-hormonal birth control during treatment, and for 1 month after your last dose.
- Birth control pills (oral contraceptives) and other hormonal forms of birth control may not work as well during treatment.
- Talk to your healthcare provider about birth control methods that might be right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment.
Males who have female partners who are able to become pregnant:
- You should use effective birth control during treatment and for 1 week after your last dose.
- are breastfeeding or plan to breastfeed. It is not known if Exkivity passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose.
What other drugs will affect Exkivity?
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider if you take medicines for heart problems.
Exkivity and other medicines may affect each other causing serious side effects.
Especially tell your doctor if you are taking the following medicines:
- antibiotics - clarithromycin, erythromycin, ciprofloxacin
- antifungal medicines - fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
- heart or blood pressure medicine - amiodarone, diltiazem, verapamil
- HIV medicines containing ritonavir, darunavir, indinavir, nelfinavir, saquinavir or cobicistat
- antipsychotics - chlorpromazine, haloperidol, droperidol, quetiapine, olanzapine, amisulpride, thioridazine
- antiarrhythmics - quinidine, procainamide, disopyramide, flecainide, sotalol, amiodarone
- antidepressants - fluvoxamine, amitriptyline, doxepin, imipramine, nortriptyline, desipramine, citalopram, escitalopram, venlafaxine, bupropion
- antihistamines - diphenhydramine, loratadine
How should I take Exkivity?
- Take Exkivity exactly as your healthcare provider tells you to take it.
- Take your prescribed dose of Exkivity 1 time each day.
- Take Exkivity with or without food.
- Swallow Exkivity capsules whole. Do not open, chew, or dissolve the contents of the capsules.
- Do not change your dose or stop treatment unless your healthcare provider tells you to.
- Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment if you develop certain side effects.
- If you miss a dose, and it has been more than 6 hours, skip the dose and take your next dose at your regularly scheduled time the next day.
- If you vomit a dose, do not take an extra dose. Take your next dose at your regularly scheduled time the next day.
What should I avoid while taking Exkivity?
- Avoid eating grapefruit or drinking grapefruit juice during treatment. Grapefruit may increase the amount of Exkivity in your blood.
Usual Adult Dose of Exkivity for EGFR Exon20 Insertion+ Non-Small Cell Lung Cancer
- 160 mg orally once daily, with or without food.
Use: treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Exkivity side effects
Exkivity may cause serious side effects, including:
See Important information.
- Lung problems. Exkivity may cause severe lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you develop any new or worsening symptoms, including trouble breathing or shortness of breath, cough, chest pain, or fever.
- Heart problems, including heart failure. Exkivity may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start and during treatment. Tell your healthcare provider right away if you have any signs or symptoms of a heart problem, including feeling like your heart is pounding or racing, shortness of breath, chest pain, swelling of your ankles and feet, or feeling faint.
- Diarrhea. Diarrhea is common during treatment, and may sometimes be severe. Diarrhea can cause you to lose too much body fluid (dehydration) and kidney problems. Your healthcare provider may tell you to start drinking more fluids and electrolytes to replace body salts or start taking your antidiarrheal medicines. Tell your healthcare provider right away if you have any loose stools or have stools more often than is normal for you.
The most common side effects include:
- mouth sores
- decrease appetite
- infection of skin around nails
- dry skin
- muscle or bone pain
Exkivity may affect fertility in females and males, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Exkivity?
- Store Exkivity at room temperature between 68°F to 77°F (20°C to 25°C).
Keep all medicines out of the reach of children and pets.
General information about the safe and effective use of Exkivity.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.
What are the ingredients in Exkivity?
Active ingredient: mobocertinib
Inactive ingredients: None
Capsule shells: gelatin and titanium dioxide. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.
How does Exkivity (mobocertinib) work?
Exkivity is a kinase inhibitor of epidermal growth factor receptor (EGFR). Kinases are enzymes that control different cell functions and may help cancer cells to grow. Specifically, Exkivity irreversibly attaches to and inhibits (blocks) EGFR exon 20 insertion mutations associated with non-small cell lung cancer (NSCLC) to help slow down tumor growth. It is a first-in-class oral therapy specifically designed to target EGFR Exon 20 insertion mutations.
Who manufactures Exkivity (mobocertinib)?
Exkivity is manufactured by Takeda Pharmaceuticals. The U.S. headquarters for Takeda is in Lexington, MA. You can contact the Oncology customer support team at Takeda Pharmaceuticals by calling 1-844-817-6468, option 2, M-F 8AM to 8PM, or online through the Takeda Oncology Here2Assist website.
Is Exkivity (mobocertinib) a chemotherapy drug?
Exkivity is not considered a chemotherapy treatment. It is a targeted anticancer drug therapy taken once a day as oral capsules. Targeted drug therapies find and attack specific types of cancer cells to help slow down tumor growth. Specifically, Exkivity is a first-in-class oral kinase inhibitor indicated for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
There are no head-to-head comparative studies of Exkivity to Rybrevant, so it is not possible to say if one is better than the other. In clinical studies, both treatments led to responses in some patients: Close to 28% of patients had a partial response (tumor shrinkage) to Exkivity treatment and the response lasted for about 17.5 months. About 40% of participants had a response to Rybrevant treatment, and the duration of response (DoR) lasted for a median of 11.5 months. Continue reading
In clinical studies, 32 of 114 patients (28%) with NSCLC had a partial response to Exkivity treatment. In these patients, the response to treatment lasted for about 17.5 months. Close to 59% of patients who responded had a response that lasted at least 6 months Continue reading
More about Exkivity (mobocertinib)
- Check interactions
- Pricing & coupons
- Drug images
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: EGFR inhibitors
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