deferoxamine mesylate for injection, USP Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Caution patients about the potential allergic reactions associated with rapid intravenous administration of Deferoxamine Mesylate for injection and the need for monitoring allergic reactions during treatment [see Warnings and Precautions (5.1)].

Caution patients about the potential auditory and ocular toxicities due to prolonged use of Deferoxamine Mesylate for injection, conduct auditory testing and ophthalmic testing at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment [see Warnings and Precautions (5.2)].

Caution patients about the potential for kidney toxicity when taking Deferoxamine Mesylate for injection and the need for kidney function test to monitor for increase in serum creatinine [see Warnings and Precautions (5.3)].

Inform patients that if they have difficulty in breathing during treatment, they should inform the health care provider as this is a symptom of acute respiratory distress syndrome which can occur with excessively high intravenous doses of Deferoxamine Mesylate for injection [see Warnings and Precautions (5.4)].

Caution pediatric patients and their caregivers that child treated with Deferoxamine Mesylate for injection could have slower than normal growth and the need to monitor for body weight and height every 3 months [see Warnings and Precautions (5.5)].

Caution patients about the increased risk of bacterial infections (Yersinia enterocolitica and Yersinia pseudotuberculosis) with Deferoxamine Mesylate for injection treatment and the need for treatment discontinuation until the infection is resolved [see Warnings and Precautions (5.6)].

Caution patients about the potential risk of fungal infections (Mucormycosis) when receiving Deferoxamine Mesylate for injection treatment and the need for treatment discontinuation, mycological tests and required treatment for treating the infection [see Warnings and Precautions (5.6)].

Caution patients about the potential impairment of cardiac function when taking Deferoxamine Mesylate for injection concomitantly with high doses of Vitamin C (more than 500 mg daily in adults). Inform adult patients not to exceed a daily Vitamin C dose of 200 mg given in divided doses. Inform pediatric patients under 10 years of age and older pediatric patients or their care takers not to exceed a daily Vitamin C of 50 mg and 100 mg, respectively [see Dosage and Administration (2.4) and Warnings and Precautions (5.7)].

Inform patients with cardiac failure not to take Vitamin C supplements when on treatment with Deferoxamine Mesylate for injection [see Dosage and Administration (2.4) and Warnings and Precautions (5.7)].

Caution patients with aluminum-related encephalopathy and receiving dialysis about potential neurological dysfunction [see Warnings and Precautions (5.8)].

Cautions patients that treatment with Deferoxamine Mesylate for injection in the presence of aluminum overload may result in decreased serum calcium and aggravation of hyperparathyroidism [see Warnings and Precautions (5.8)].

Inform patients that they should refrain from driving or operating potentially hazardous machines if they experience dizziness or other nervous system disturbances, or impairment of vision or hearing [see Warnings and Precautions (5.9)].

Advise patients to inform the healthcare provider if they have received prochlorperazine prior to Deferoxamine Mesylate for injection treatment as this may lead to temporary impairment of consciousness [see Drug Interactions (7.1)].

Inform patients that if they are going for any imaging tests while receiving Gallium-67 and Deferoxamine mesylate concomitantly it can result in reports with distorted images [see Drug Interactions (7.2)].

Inform patients that their urine may occasionally show a reddish discoloration.

Embryo-fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.10), Use in Specific Populations (8.1, 8.3)].

Advise females of reproductive potential to use effective contraceptive during treatment with Deferoxamine Mesylate for injection and for one month after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise patients to avoid breastfeeding while taking Deferoxamine Mesylate for injection and for one week after the final dose [see Use in Specific Populations (8.2)].

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                  Logo

LAB-1006-5.0

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Caution patients about the potential allergic reactions associated with rapid intravenous administration of Deferoxamine Mesylate for injection and the need for monitoring allergic reactions during treatment [see Warnings and Precautions (5.1)].

Caution patients about the potential auditory and ocular toxicities due to prolonged use of Deferoxamine Mesylate for injection, conduct auditory testing and ophthalmic testing at regular intervals. Advise patients to contact their healthcare provider if they develop visual or auditory changes during treatment [see Warnings and Precautions (5.2)].

Caution patients about the potential for kidney toxicity when taking Deferoxamine Mesylate for injection and the need for kidney function test to monitor for increase in serum creatinine [see Warnings and Precautions (5.3)].

Inform patients that if they have difficulty in breathing during treatment, they should inform the health care provider as this is a symptom of acute respiratory distress syndrome which can occur with excessively high intravenous doses of Deferoxamine Mesylate for injection [see Warnings and Precautions (5.4)].

Caution pediatric patients and their caregivers that child treated with Deferoxamine Mesylate for injection could have slower than normal growth and the need to monitor for body weight and height every 3 months [see Warnings and Precautions (5.5)].

Caution patients about the increased risk of bacterial infections (Yersinia enterocolitica and Yersinia pseudotuberculosis) with Deferoxamine Mesylate for injection treatment and the need for treatment discontinuation until the infection is resolved [see Warnings and Precautions (5.6)].

Caution patients about the potential risk of fungal infections (Mucormycosis) when receiving Deferoxamine Mesylate for injection treatment and the need for treatment discontinuation, mycological tests and required treatment for treating the infection [see Warnings and Precautions (5.6)].

Caution patients about the potential impairment of cardiac function when taking Deferoxamine Mesylate for injection concomitantly with high doses of Vitamin C (more than 500 mg daily in adults). Inform adult patients not to exceed a daily Vitamin C dose of 200 mg given in divided doses. Inform pediatric patients under 10 years of age and older pediatric patients or their care takers not to exceed a daily Vitamin C of 50 mg and 100 mg, respectively [see Dosage and Administration (2.4) and Warnings and Precautions (5.7)].

Inform patients with cardiac failure not to take Vitamin C supplements when on treatment with Deferoxamine Mesylate for injection [see Dosage and Administration (2.4) and Warnings and Precautions (5.7)].

Caution patients with aluminum-related encephalopathy and receiving dialysis about potential neurological dysfunction [see Warnings and Precautions (5.8)].

Cautions patients that treatment with Deferoxamine Mesylate for injection in the presence of aluminum overload may result in decreased serum calcium and aggravation of hyperparathyroidism [see Warnings and Precautions (5.8)].

Inform patients that they should refrain from driving or operating potentially hazardous machines if they experience dizziness or other nervous system disturbances, or impairment of vision or hearing [see Warnings and Precautions (5.9)].

Advise patients to inform the healthcare provider if they have received prochlorperazine prior to Deferoxamine Mesylate for injection treatment as this may lead to temporary impairment of consciousness [see Drug Interactions (7.1)].

Inform patients that if they are going for any imaging tests while receiving Gallium-67 and Deferoxamine mesylate concomitantly it can result in reports with distorted images [see Drug Interactions (7.2)].

Inform patients that their urine may occasionally show a reddish discoloration.

Embryo-fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.10), Use in Specific Populations (8.1, 8.3)].

Advise females of reproductive potential to use effective contraceptive during treatment with Deferoxamine Mesylate for injection and for one month after the last dose [see Use in Specific Populations (8.3)].

Lactation

Advise patients to avoid breastfeeding while taking Deferoxamine Mesylate for injection and for one week after the final dose [see Use in Specific Populations (8.2)].

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                  Logo

LAB-1006-5.0

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