Mobocertinib

Generic name: Mobocertinib
Brand names: Exkivity
Dosage form: oral capsule
Drug class: EGFR inhibitors

Usage of Mobocertinib

Mobocertinib is a type of drug called a kinase inhibitor, which is used to treat a rare type of non-small cell lung cancer (NSCLC).

Mobocertinib is used to treat NSCLC caused by a specific type of gene mutation called an epidermal growth factor receptor (EGFR) exon 20 insertion mutation. Only about 2000 to 4000 people are diagnosed with this type of cancer in the US each year.

EGFR is a protein that helps cells to grow and divide. When an exon 20 insertion mutation occurs, it drives cells to grow and divide abnormally, causing an EGFR-positive cancer.

Mobocertinib works by binding to and blocking EGFR exon 20 insertion mutations, which helps to slow the growth of cancer cells.

Mobocertinib was granted accelerated approval by the US Food and Drug Administration (FDA) in 2021. It is used with the Oncomine Dx Target Test, which identifies patients with exon 20 insertion mutations.

Mobocertinib side effects

Mobocertinib may cause serious side effects, including:

See "Important information" above.

Lung problems. Mobocertinib 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

fever

Heart problems, including heart failure. Mobocertinib may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start and during treatment with mobocertinib. 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

feeling faint

Diarrhea. Diarrhea is common during treatment with mobocertinib, 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 of mobocertinib include:

diarrhea

rash

nausea

mouth sores

vomiting

decrease appetite

infection of skin around nails

tiredness

dry skin

muscle or bone pain

Mobocertinib 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 of mobocertinib.

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

Before taking Mobocertinib

Tell your doctor if you are pregnant or plan to become pregnant. Mobocertinib can harm your unborn baby.

Females who are able to become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with mobocertinib.

You should use an effective form of non-hormonal birth control during treatment and for 1 month after your last dose of mobocertinib.

Birth control pills (oral contraceptives) and other hormonal forms of birth control may not work as well during treatment with mobocertinib.

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 with mobocertinib.

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 of mobocertinib.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if mobocertinib passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of mobocertinib.

Relate drugs

How to use Mobocertinib

The recommended dose of mobocertinib is 160 mg taken orally once a day. Mobocertinib can be taken with or without food.

See full prescribing information for further details about mobocertinib dosing.

Warnings

Mobocertinib 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 with mobocertinib. Tell your healthcare provider right away if you feel dizzy, lightheaded, faint or have an irregular heartbeat.

See "What are the side effects of mobocertinib?" below for more information about side effects.

What other drugs will affect Mobocertinib

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.

Mobocertinib and other medicines may affect each other causing serious side effects.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.