Drug Insights

Is Zanubrutinib approved by the FDA?

26 June 2024
3 min read

Yes, Zanubrutinib, marketed under the brand name Brukinsa, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Zanubrutinib on November 14, 2019. This approval was for the treatment of certain B-cell cancers, specifically mantle cell lymphoma (MCL) in patients who have received at least one prior treatment.

What is Zanubrutinib?

Zanubrutinib is a second-generation Bruton tyrosine kinase (BTK) inhibitor. It works by blocking the BTK protein, which plays a crucial role in the growth and multiplication of B-cells. By inhibiting this protein, Zanubrutinib helps to stop the proliferation of cancerous B-cells.

Indications and Usage

Zanubrutinib is prescribed for the treatment of adults with:

  • Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
  • Waldenström's Macroglobulinemia (WM)
  • Mantle Cell Lymphoma (MCL): For patients who have received at least one prior treatment.
  • Marginal Zone Lymphoma (MZL): For patients whose cancer has returned or did not respond to treatment after at least one anti-CD20-based regimen.
  • Relapsed or Refractory Follicular Lymphoma (FL): In combination with obinutuzumab, after two or more lines of systemic therapy.

Dosage and Administration

Zanubrutinib is available in oral capsule form, with the recommended dosage being 160 mg taken twice daily or 320 mg once daily. The capsules should be swallowed whole with water and can be taken with or without food. Patients with severe hepatic impairment may require a reduced dose.

Side Effects

Common Side Effects

  • Decreased white blood cells
  • Upper respiratory tract infection
  • Decreased platelet count
  • Bleeding
  • Rash
  • Muscle or joint pain

Serious Side Effects

  • Bleeding problems (hemorrhage): Increased risk if taken with blood thinners.
  • Infections: Can be serious and potentially fatal.
  • Decreased blood cell counts: Including white blood cells, platelets, and red blood cells.
  • Second primary cancers: Including skin cancers and other organ cancers.
  • Heart rhythm problems: Such as atrial fibrillation and atrial flutter.

Warnings and Precautions

Patients should inform their healthcare provider about any medical conditions before starting Zanubrutinib, especially if they have:

  • Bleeding problems
  • Recent or planned surgeries
  • Infections
  • Heart rhythm problems
  • High blood pressure
  • Liver problems, including hepatitis B

Pregnancy and Breastfeeding

Zanubrutinib can harm an unborn baby. Women who can become pregnant should use effective birth control during treatment and for at least one week after the last dose. Men should also use effective contraception during treatment and for at least one week after the last dose. Breastfeeding is not recommended during treatment and for two weeks after the last dose.

Storage

Zanubrutinib capsules should be stored at room temperature, between 68°F to 77°F (20°C to 25°C), in a bottle with a child-resistant cap. Keep the medication out of reach of children.

Conclusion

Zanubrutinib (Brukinsa) is an FDA-approved medication used to treat various B-cell cancers. Approved in November 2019, it offers a targeted therapy option by inhibiting Bruton's tyrosine kinase, crucial for B-cell growth. Patients should follow their healthcare provider's instructions and be aware of potential side effects and necessary precautions.

How to obtain the latest development progress of all drugs?

In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

图形用户界面, 文本, 应用程序, 电子邮件

描述已自动生成

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

Sarepta Therapeutics Gains Expanded FDA Approval for ELEVIDYS in Duchenne Muscular Dystrophy Patients Aged 4+
Latest Hotspot
3 min read
Sarepta Therapeutics Gains Expanded FDA Approval for ELEVIDYS in Duchenne Muscular Dystrophy Patients Aged 4+
26 June 2024
Sarepta Therapeutics Announces Expanded US FDA Approval of ELEVIDYS to Duchenne Muscular Dystrophy Patients Ages 4 and Above.
Read →
Is Cefiderocol approved by the FDA?
Drug Insights
3 min read
Is Cefiderocol approved by the FDA?
26 June 2024
The U.S. Food and Drug Administration (FDA) approved Cefiderocol on November 14, 2019, for the treatment of complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP).
Read →
Is Reblozyl approved by the FDA?
Drug Insights
4 min read
Is Reblozyl approved by the FDA?
26 June 2024
The U.S. Food and Drug Administration (FDA) approved Reblozyl on November 8, 2019, for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Read →
The Latest Review Provides Detailed Analysis of CAR-NK and CAR-T Cell Therapies
Hot Spotlight
8 min read
The Latest Review Provides Detailed Analysis of CAR-NK and CAR-T Cell Therapies
26 June 2024
The improved version of CAR-T therapy, CAR-NK therapy, has recently attracted considerable attention from the academic and pharmaceutical sectors due to its increased tumor-specific targeting and cytotoxicity, cost-effectiveness and easier availability of NK cells, shorter large-scale production cycles, and enhanced efficacy in treating solid tumors.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.