Umbralisib

What is Umbralisib?

• Umbralisib (UKONIQ) is a kinase inhibitor.

What are the uses of this medicine?

This medicine is used to treat adults with: Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of prior treatment. Follicular lymphoma (FL) when the disease has come back or did not respond to treatment and who have received at least three prior treatments.

How does this medicine work?

• An orally bioavailable, selective inhibitor of the delta isoform of the 110 kDa catalytic subunit of class I phosphoinositide-3 kinases (PI3K) with potential antineoplastic activity.
• Umbralisib inhibits PI3K and prevents the activation of the PI3K/AKT kinase signaling pathway.
• This decreases proliferation and induces cell death in susceptible tumor cells.
• Unlike other isoforms of PI3K, PI3K-delta is expressed primarily in tumor cells and cells of the hematopoietic lineage.
• The targeted inhibition of PI3K-delta allows for PI3K signaling in normal, non-neoplastic cells.
• PI3K, an enzyme often overexpressed in cancer cells, plays a crucial role in tumor cell regulation and survival.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

Recommended Dosage

• The recommended dosage of UKONIQ is 800 mg taken orally once daily with food [see Clinical Pharmacology (12.3)] until disease progression or unacceptable toxicity.
• Manage toxicity using treatment interruption, dose reduction, or discontinuation.

Administration

• Take UKONIQ exactly as your healthcare provider tells you.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking UKONIQ, if you develop side effects. Do not change your dose or stop taking UKONIQ without talking to your healthcare provider first.
• Take UKONIQ tablets 1 time each day with food at about the same time each day.
• Swallow UKONIQ tablets whole. Do not crush, break, cut or chew the tablets.
• If you vomit after taking a dose of UKONIQ, do not take another dose on that day. Take your next dose at your usual time.
• If you miss a dose of UKONIQ, take it as soon as you remember on the same day. If it has been more than 12 hours, skip the missed dose and take your next dose on the next day at your usual time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: 200 mg

This medicine is available in fallowing brand namesː

• UKONIQ

What side effects can this medication cause?

The most common side effects of this medicine include:

• changes in certain kidney function
• blood tests
• tiredness
• nausea
• muscle or bone pain
• low red blood cell count (anemia)
• low platelet count
• upper respiratory tract infection
• vomiting
• abdominal pain
• decreased appetite

UKONIQ can cause serious side effects, including:

• Infections
• Low white blood cell count (neutropenia)
• Diarrhea or inflammation of your intestine (colitis)
• Liver problems
• Severe skin reactions

What special precautions should I follow?

• Monitor for fever and any new or worsening signs and symptoms of infection. Evaluate promptly and treat as needed.
• This medicine may cause neutropenia. Monitor blood counts during treatment.
• Monitor for the development of diarrhea or colitis and provide supportive care as appropriate
• Hepatotoxicity may occur. Monitor hepatic function.
• Withhold treatment, reduce dose, or discontinue treatment depending on severity and persistence of severe cutaneous reaction.
• UKONIQ contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions.
• This medicine Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• UKONIQ can cause fetal harm when administered to a pregnant woman.
• There are no available data on UKONIQ use in pregnant women to evaluate for a drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness of UKONIQ have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store UKONIQ tablets at room temperature between 68°F to 77°F (20°C to 25°C).

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• Dailymed label info on Umbralisib
• FDA Umbralisib