Dabrafenib instructions

1. All names:Dabrafenib,Dabrafenib mesylate capsules,Dabrafenib,dabrafenib

Product name:Tafinlar

2. Indications and usage

Dabrafenib is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma in whom the BRAF V600E mutation has been detected in an FDAapproved test.

This product is suitable for combined use with trametinib for:

1. FDAapproved the treatment of patients with unresectable or metastatic melanoma who have a BRAF V600E or V600K mutation detected in an FDA trial.

2.Adjuvant therapy for patients with melanoma with BRAF V600E or V600K mutations and lymph node involvement after complete resection based on FDA-approved testing.

3. FDATreatment of patients with metastatic non-small cell lung cancer(non-small cell lung cancer) with BRAF V600E mutation detected in FDAtest.

4.Treatment of patients with locally advanced or metastatic anaplastic thyroid cancer(ATC) who have the BRAF V600E mutation and who have no satisfactory locoregional treatment options.

5.Yes1years old andFor the treatment of adult and pediatric patients aged 1 year and older with unresectable or metastatic BRAF V600E mutant solid tumors who have progressed after prior therapy and for whom there are no satisfactory alternative treatment options. This indication received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and characterization of clinical benefit in confirmatory trials.

Treatment of pediatric patients aged 6.1 and older with BRAF V600Emutated low-grade glioma(LGG) requiring systemic therapy.

Restrictions on Use:Dabrafenib is not indicated for the treatment of patients with colorectal cancer due to known inherent resistance to BRAF inhibition. Dabrafenib is not indicated for the treatment of patients with wild-type BRAF solid tumors.

Three. Dosage and usage

The recommended dose for adult patients is 150 mg (two 75 mg capsules) taken orally twice daily. Recommended dosage for pediatric patients is based on body weight. Take dabrafenib at least1 hour before a meal or 2 hours after a meal.

Four. Dosage form and strength

Dabrafenib:50mg, 75mg

Five. Contraindications

No.

6. Things to note

1.Cutaneous and non-cutaneous primary malignancies:May occur when dabrafenib is administered as a single agent or with trametinib. Monitor patients for new malignancies before, during, and after discontinuation of treatment.

2. BRAFTumor promotion in wild-type tumors: BRAF inhibitors increase cell proliferation.

3.Bleeding:AcceptSerious bleeding events may occur in patients treated with dabrafenib combined with trametinib. Monitor for signs and symptoms of bleeding.

4.Cardiomyopathy:Before treatment withdabrafeniband trametinib, one month after treatment, and every time thereafter2 to 3 months.

5.Uveitis:Perform an ophthalmic evaluation for any visual impairment.

6.Severe febrile reactions:Dabrafenib and trametinib may increase the incidence and severity of fever.

7.Severe Skin Toxicity:Monitor for skin toxicity. For intolerable grade 2 or 3 or 4 grade rash, if there is no improvement within 3 weeks even if dabrafenib is discontinued, stop taking the drug. Permanently discontinued due to serious adverse skin reactions(scarring).

8.Hyperglycemia:Monitor blood sugar levels in patients with pre-existing diabetes or high blood sugar.

9.Glucose-6-Phosphate dehydrogenase deficiency(G6PD):Closely monitor for hemolytic anemia.

10.Hemophagocytic lymphohistiocytosis(HLH):Interrupt treatment for suspected HLH. If HLH is diagnosed, stop treatment.

11.Embryo-Fetal Toxicity:Can cause fetal harm. Inform women of the potential reproductive risks to the fetus and use an effective non-hormonal method of contraception.

7. adverse reactions

DabrafenibThe most common adverse reactions as a single drug(≥ 20%)is a syndrome of hyperkeratosis, headache, fever, arthralgia, papilloma, alopecia, and palmar-plantar red paresthesias.

The most common adverse reactions of dabrafenib combined with trametinib(≥ 20%)includes:

Unresectable or metastatic melanoma:Fever, rash, chills, headache, joint pain, and cough.

Adjuvant treatment of melanoma:Fever, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia and myalgia.

Non-small cell lung cancer:Fever, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, bleeding, cough and difficulty breathing.

Adult patients with solid tumors:Fever, fatigue, nausea, rash, chills, headache, bleeding, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.

Children with solid tumors:Fever, rash, vomiting, fatigue, dry skin, cough, diarrhea, acneiform dermatitis, headache, abdominal pain, nausea, bleeding, constipation and paronychia.

LGGPediatric patients:Fever, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, bleeding, abdominal pain, and acneiform dermatitis.

8. drug interactions

Avoid concurrent use of strong inhibitors of CYP3A4 or CYP2C8.

With actionsCYP3A4, CYP2C8, CYP2C9 Coadministration of drugs that are sensitive substrates of pan>, CYP2C19 or CYP2B6 may render these drugs ineffective.

9. Used by specific groups of people

Breastfeeding:Do not breastfeed.

Women and men of reproductive potential:May impair fertility.

The price of dabrafenib in domestic pharmacies75mg120 tablets9800 yuan. The Turkish version75mg120tabletsabout 11,000yuan. Generic drugs are produced in Laos, and the retail price of Laos pharmaceutical factories is more than 75mg120capsules2 more than 1,000. The retail price of trametinib+dabrafenib is more than 4 thousand per set. Patients can choose drug versions based on their financial situation. If you want to get more high-quality information, you can contact Yaode. Yade will do its best to learn more about high-quality overseas drugs for you.

xa0