Is Ripretinib approved by the FDA?
Yes, Ripretinib, marketed under the brand name Qinlock, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Ripretinib on May 15, 2020, for the treatment of advanced gastrointestinal stromal tumor (GIST) in adult patients who have received prior treatment with three or more kinase inhibitors, including imatinib.
What is Ripretinib?
Ripretinib is an oral multikinase inhibitor used to treat tumors of the stomach and intestines, specifically gastrointestinal stromal tumors (GIST). It is indicated for use in adults who have already been treated with at least three other cancer medicines.
How Does Ripretinib Work?
Ripretinib targets multiple kinases involved in cancer cell growth, including KIT and PDGFRA kinases. These kinases are often mutated in GIST, driving tumor growth. By inhibiting these kinases, Ripretinib can help slow or stop the progression of the disease.
Dosage and Administration
Ripretinib is available in oral tablet form (50 mg). The recommended dose for adults is 150 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. Tablets should be swallowed whole and not crushed, chewed, or broken.
Side Effects
Common side effects of Ripretinib include:
- Nausea, vomiting, stomach pain, loss of appetite
- Diarrhea, constipation
- Tiredness
- Muscle pain
- Thinning hair, hair loss
Serious side effects may include:
- Severe stomach pain, nausea, or vomiting
- Severe headache, blurred vision, pounding in your neck or ears
- Pain, blisters, bleeding, or severe rash in the palms of your hands or the soles of your feet
- Heart problems (e.g., tiredness, feeling short of breath, swollen veins in the neck, swelling in the stomach or lower legs)
- Low red blood cells (anemia)
- Skin changes (e.g., new warts, skin sores, red bumps that bleed or do not heal, or changes in the size or color of moles)
Warnings and Precautions
- Ripretinib can increase the risk of developing skin cancer. Regular skin checks are recommended.
- Patients should use effective birth control during treatment and for at least one week after the last dose to prevent pregnancy, as Ripretinib can harm an unborn baby.
- Breastfeeding is not recommended during treatment and for at least one week after the last dose.
- Inform your healthcare provider of any existing conditions, such as high blood pressure or heart problems, before starting Ripretinib.
Conclusion
Ripretinib (Qinlock) is a targeted therapy approved by the FDA for the treatment of advanced GIST in patients who have previously been treated with multiple kinase inhibitors. Approved on May 15, 2020, it offers a new option for patients with this challenging and aggressive form of cancer. As with any medication, it is essential to follow the prescribing doctor's instructions and report any side effects promptly.
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