Belumosudil

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Approved Treatment Indication:

Graft vs Host Disease

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Summary

What conditions is Belumosudil used for?
Belumosudil is used to treat chronic graft-versus-host disease (GVHD) in patients aged 12 years and older who have not responded to at least two prior treatments. GVHD is a condition that can occur after a stem cell or bone marrow transplant, where the donated cells attack the recipient's body.
How does Belumosudil work in the body?
Belumosudil works by inhibiting certain proteins called kinases that contribute to GVHD. This helps to reduce inflammation and improve symptoms.
What are the usual dosages and routes of administration for Belumosudil?
The usual daily dose of Belumosudil for both adults and children aged 12 years and older is 200 mg taken orally once a day with a meal. It's important to take it at the same time each day.
What are the most commonly observed adverse effects of Belumosudil?
Common side effects of Belumosudil include infections, tiredness or weakness, nausea, diarrhea, and headache. More serious side effects can include severe liver issues and unusual bleeding or bruising.
What are some important safety warnings and contraindications for Belumosudil?
Belumosudil can cause harm to a fetus, so it's important for pregnant women and those who can become pregnant to use effective contraception. It may also affect liver function, so regular blood tests are necessary. Patients with moderate to severe liver impairment should avoid using Belumosudil.

Government Approvals

US(FDA)

WHO Essential Medicine

NO

Known Teratogen

No

Pharmaceutical Class

NA

Controlled Drug Substance

No

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Drug Ingredient

Belumosudil

Summary

What conditions is Belumosudil used for?
Belumosudil is used to treat chronic graft-versus-host disease (GVHD) in patients aged 12 years and older who have not responded to at least two prior treatments. GVHD is a condition that can occur after a stem cell or bone marrow transplant, where the donated cells attack the recipient's body.
How does Belumosudil work in the body?
Belumosudil works by inhibiting certain proteins called kinases that contribute to GVHD. This helps to reduce inflammation and improve symptoms.
What are the usual dosages and routes of administration for Belumosudil?
The usual daily dose of Belumosudil for both adults and children aged 12 years and older is 200 mg taken orally once a day with a meal. It's important to take it at the same time each day.
What are the most commonly observed adverse effects of Belumosudil?
Common side effects of Belumosudil include infections, tiredness or weakness, nausea, diarrhea, and headache. More serious side effects can include severe liver issues and unusual bleeding or bruising.
What are some important safety warnings and contraindications for Belumosudil?
Belumosudil can cause harm to a fetus, so it's important for pregnant women and those who can become pregnant to use effective contraception. It may also affect liver function, so regular blood tests are necessary. Patients with moderate to severe liver impairment should avoid using Belumosudil.

Indications and Purpose

How does Belumosudil work?

Belumosudil works by inhibiting rho-associated, coiled-coil containing protein kinase (ROCK), which plays a role in inflammation and fibrosis. By blocking these proteins, Belumosudil helps reduce the symptoms of chronic graft-versus-host disease (GVHD) and improves patient outcomes.

Is Belumosudil effective?

Belumosudil has been shown to be effective in treating chronic graft-versus-host disease (GVHD) in patients who have not responded to at least two prior treatments. In clinical trials, the overall response rate was 75%, with a median duration of response of 1.9 months. These results support its use in managing chronic GVHD.

What is Belumosudil?

Belumosudil is used to treat chronic graft-versus-host disease (GVHD) in patients 12 years and older who have not responded to at least two prior treatments. It works by inhibiting certain proteins (kinases) that contribute to the disease, helping to reduce inflammation and improve symptoms. Regular monitoring by a healthcare provider is essential during treatment.

Directions for Use

For how long do I take Belumosudil?

Belumosudil is typically used until the progression of chronic graft-versus-host disease (GVHD) that requires new systemic therapy. The exact duration can vary based on individual response and medical advice.

How do I take Belumosudil?

Take Belumosudil once daily with a meal, at the same time each day. Swallow the tablets whole with a glass of water, without cutting, crushing, or chewing them. There are no specific food restrictions, but always follow your doctor's instructions.

How long does it take for Belumosudil to start working?

The median time to first response for Belumosudil is approximately 1.8 months. However, the exact time can vary depending on individual response and medical condition. Regular follow-ups with your doctor will help assess the effectiveness of the treatment.

How should I store Belumosudil?

Store Belumosudil at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container with the desiccant packet to protect from moisture. Ensure the bottle is tightly closed after each use and keep it out of reach of children.

What is the usual dose of Belumosudil?

The usual daily dose of Belumosudil for both adults and children aged 12 years and older is 200 mg taken orally once a day with a meal. It is important to take it at the same time each day.

Warnings and Precautions

Can Belumosudil be taken safely while breastfeeding?

Women are advised not to breastfeed during treatment with Belumosudil and for at least one week after the last dose due to the potential for serious adverse reactions in the breastfed child. Consult your doctor for personalized advice.

Can Belumosudil be taken safely while pregnant?

Belumosudil can cause fetal harm based on animal studies. Women who are pregnant or can become pregnant should use effective contraception during treatment and for one week after the last dose. A pregnancy test is required before starting treatment. If pregnancy occurs, inform your doctor immediately.

Can I take Belumosudil with other prescription drugs?

Belumosudil interacts with strong CYP3A inducers and proton pump inhibitors, which can decrease its effectiveness. If you are taking these medications, your doctor may adjust your Belumosudil dosage. Always inform your healthcare provider about all medications, vitamins, and supplements you are taking to avoid potential interactions.

Is Belumosudil safe for the elderly?

In clinical studies, 26% of patients with chronic GVHD were 65 years and older. No significant differences in safety or effectiveness were observed between older and younger patients. However, elderly patients should use Belumosudil under medical supervision, considering their overall health and any other medications they may be taking.

Who should avoid taking Belumosudil?

Belumosudil can cause fetal harm, so it is important for pregnant women and those who can become pregnant to use effective contraception. It may also affect liver function, so regular blood tests are necessary. Patients with moderate to severe liver impairment should avoid using Belumosudil. Always inform your doctor of any other medications you are taking to avoid interactions.