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FARXIGA (DAPAGLIFLOZIN): PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide): Farxiga medication guide

Instructions

Instruct patients to read the Medication Guide before starting treatment with Dapagliflozin (Farxiga) tablets and to reread it each time the prescription is renewed.

Inform patients of the potential risks and benefits of Farxiga and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment of diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change.

Instruct patients to take Farxiga (Dapagliflozin Propanediol Monohydrate) only as prescribed. If a dose is missed, advise patients to take it as soon as it is remembered unless it is almost time for the next dose, in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time. Advise patients not to take two doses of Farxiga at the same time.

Inform patients that the most common adverse reactions associated with use of Farxiga (Dapagliflozin) are genital mycotic infections, nasopharyngitis, and urinary tract infections.

Instruct patient to immediately inform her healthcare provider if she is pregnant or plans to become pregnant. Based on animal data, Farxiga (Dapagliflozin) tablets may cause fetal harm in the second and third trimesters of pregnancy.

Instruct patient to immediately inform her healthcare provider if she is breastfeeding or planning to breastfeed. It is not known if Farxiga is excreted in breast milk; however, based on animal data, this medication may cause harm to nursing infants.

Hypotension

Inform patients that symptomatic hypotension may occur with Dapagliflozin (Farxiga) and advise them to contact their healthcare provider if they experience such symptoms. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.

Genital Mycotic Infections in Females (e.g., Vulvovaginitis)

Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections. Advise them of treatment options and when to seek medical advice.

Genital Mycotic Infections in Males (e.g., Balanitis)

Inform male patients that yeast infections of the penis (e.g., balanitis or balanoposthitis) may occur, especially in patients with prior history. Provide them with information on the signs and symptoms of balanitis and balanoposthitis (rash or redness of the glans or foreskin of the penis). Advise them of treatment options and when to seek medical advice.

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions (e.g., urticaria and angioedema) have been reported with Dapagliflozin (Farxiga) tablets. Advise patients to immediately report any signs or symptoms suggesting allergic reaction or angioedema, and to take no more of the drug until they have consulted prescribing physicians.

Urinary Tract Infections

Inform patients of the potential for urinary tract infections. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur.

Bladder Cancer

Inform patients to promptly report any signs of macroscopic hematuria or other symptoms potentially related to bladder cancer.

Laboratory Tests

Due to its mechanism of action, patients taking Farxiga (Dapagliflozin Propanediol Monohydrate) will test positive for glucose in their urine.

Manufactured and distributed by AstraZeneca, Bristol-Myers Squibb pharmaceutical companies and their divisions.

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