H.P. ACTHAR(repository corticotropin)injection(十一)
roduct is stable for the period indicated on the label when stored under the conditions described.
17 PATIENT COUNSELING INFORMATION
Caretakers of patients with infantile spasms should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to administering H.P Acthar Gel. Patients should be instructed to take H.P. Acthar Gel only as prescribed. They should not stop treatment suddenly unless instructed by their physician to do so.
Patients, their caregivers and families should be advised as to the importance of the need for careful monitoring while on and during titration from H.P. Acthar Gel treatment and the importance of not missing and scheduled doctor’s appointments.
Patients, their caregivers and families should be advised that if the patient develops an infection or fever they should contact their physician. They should be educated that a fever may not necessarily be present during infection. The patient should also try to limit contact with other people with infections to minimize the risk of infection while taking H.P. Acthar Gel. [see Warnings and Precautions (5.1) and Adverse Reactions (6.1.1)]
Patients, their caregivers and families should be advised that if the patient experiences an increase in blood pressure they should contact their physician. [see Warnings and Precautions (5.3) and Adverse Reactions (6.1.1)]
Patients, their caregivers and families should be advised that if the patient or the caregiver notices blood or a change in color of the patient’s stool they should contact their physician. [see Warnings and Precautions (5.6)].
Caregivers and families of infants and children treated with H.P. Acthar Gel should be informed that the patient may show signs of irritability and sleep disturbances. These effects are reversible once H.P. Acthar Gel therapy is stopped. [see Warnings and Precautions (5.7) and Adverse Reactions (6.1.1)].
Patients, their caregivers and families should be advised that changes in appetite, most often leading to weight gain, are seen with H.P. Acthar Gel therapy, becoming more frequent as the dose or treatment period increases. These effects are reversible once H.P. Acthar Gel therapy is stopped. [see Warnings and Precautions (5.12) and Adverse Reactions (6.1.1].
Patients, their caregivers and families should be advised that the patient may be monitored for signs of adrenal insufficiency such as weakness, fatigue, lethargy, anorexia, weight loss, hypotension, abdominal pain or hyperpigmentation (adults only) after treatment has stopped. Since the recovery of the adrenal gland varies from days to months, patients may need to be protected from the stress of trauma or surgery by the use of corticosteroids during the period of stress. [see Warnings and Precautions (5.2)].
Patients should be advised not to be vaccinated with live or live attenuated vaccines during treatment with H.P. Acthar Gel. Additionally, other immunization procedures in patients or in family members who will be in contact with the patient should be undertaken with caution while the patient is taking H.P. Acthar Gel. [see Warnings and Precautions (5.4)].
Patients, their caregivers and families should be advised that prolonged use of H.P. Acthar Gel in children may result in Cushing’s syndrome and associated adverse reactions, may inhibit skeletal growth, and may cause osteoporosis and decreased bone density. If prolonged use is necessary, H.P. Actha |
