Rafinlar 50Mg Bottle Of 28 Capsules

• As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test. In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma
• BRAF V600 mutation-positive cancers, including melanoma, non-small cell lung cancer (NSCLC), anaplastic thyroid cancer (ATC), and solid tumors

• Pyrexia (fever) and chills
• Fatigue, asthenia (weakness), and headache
• Joint pain (arthralgia), muscle pain (myalgia), and back pain
• Hyperkeratosis (thickening of the skin), rash, and dry skin
• Nausea, vomiting, diarrhea, and decreased appetite
• Cough and shortness of breath

• Constipation
• Hair thinning or alopecia
• Dizziness
• Peripheral edema (swelling of hands, legs, or feet)
• Elevations in blood glucose and liver enzyme parameters

• Severe Pyrexia: High fever accompanied by severe shivering, low blood pressure, dehydration, or kidney injury (more frequent when combined with trametinib).
• Development of New skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma, new primary melanoma) or non-cutaneous cancers.
• Severe Hemorrhage: Major bleeding events, including gastrointestinal or intracranial hemorrhage.
• Eye inflammation (Uveitis) causing eye pain, redness, or blurry vision.
• Cardiomyopathy / Heart Failure: Decreased left ventricular ejection fraction, leading to severe shortness of breath and leg swelling.
• Severe Cutaneous Adverse Reactions (SCAR): Severe skin reactions such as Stevens-Johnson syndrome (SJS).
• Hemophagocytic Lymphohistiocytosis (HLH): A rare but serious condition involving overactivation of the immune system, reported when this medicine is used with trametinib; symptoms can include persistent fever, feeling very unwell, and abnormal blood test results

Other General Warnings

• You have a history of heart disease, low ejection fraction, or cardiac arrhythmias.
• You have a history of liver impairment, kidney failure, or bleeding disorders.
• You have pre-existing eye conditions or experience sudden vision changes.
• You have G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency), as Rafinlar capsule can increase the risk of hemolytic anemia (breakdown of red blood cells) in this condition
• You experience sudden severe fever, or persistent fever with feeling very unwell.
• You have a known severe hypersensitivity or systemic allergic reaction to dabrafenib or any inactive ingredient in the capsule formulation.

• Rafinlar capsule must be taken strictly as prescribed by your treating physician, at approximately the same time each day on an empty stomach, at least 1 hour before or at least 2 hours after a meal.
• Swallow the capsules whole with a full glass of water. Do not open, crush, or chew the capsules.

• Store capsules at controlled room temperature, away from excessive heat and direct moisture.
• Keep in the original container and out of reach of children and pets.
• Dispose of unused capsules according to hazardous medicine-disposal guidelines.

• Monitor your body temperature regularly. If you develop a fever, contact your oncology care team promptly.
• Report any new skin growths, warts, sores that fail to heal, or changing moles.
• Use effective non-hormonal birth control (e.g., condoms or a copper IUD) during treatment, and women should continue this for a few weeks after the last dose of Rafinlar capsule; men (including those who have had a vasectomy) should use condoms for at least a few months after the last dose when receiving combination treatment with trametinib.
• Attend all scheduled appointments for blood tests, heart scans (ECHO/MUGA), and dermatological examinations.
• Take each dose on an empty stomach, at least 1 hour before or 2 hours after eating.

Overdose

Missed a Dose

Interactions with other medicines

• Some medicines can change the amount of Rafinlar capsule in your body or be affected by it.
• Drugs like ketoconazole, clarithromycin, rifampin, or St. John’s Wort can alter dabrafenib drug levels and efficacy.
• Dabrafenib can reduce the effectiveness of oral, transdermal, or injectable hormonal contraceptives. Non-hormonal barrier methods are preferred.
• Medications that raise gastric pH may alter dabrafenib’s absorption.
• Dabrafenib is a CYP enzyme inducer and may decrease blood levels of co-administered drugs like warfarin, midazolam, or immunosuppressants.
• Tell your doctor about all prescription and over-the-counter medicines, vitamins, supplements, and herbal products you take.

Interactions with food items