Pasurta 70 mg/mL Solution for Injection in a Prefilled Syringe

AIMOVIG is indicated for the preventive treatment of migraine in adults. AIMOVIG is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of migraine in adults. ( 1 )

• For subcutaneous use only Recommended dosage is 70 mg once monthly; some patients may benefit from a dosage of 140 mg once monthly Administer in the abdomen, thigh, or upper arm subcutaneously See Dosage and Administration for important administration instructions Recommended Dosing The recommended dosage of AIMOVIG is 70 mg injected subcutaneously once monthly
• Some patients may benefit from a dosage of 140 mg injected subcutaneously once monthly
• If a dose of AIMOVIG is missed, administer as soon as possible
• Thereafter, AIMOVIG can be scheduled monthly from the date of the last dose
• Important Administration Instructions AIMOVIG is for subcutaneous use only
• AIMOVIG is intended for patient self-administration
• Prior to use, provide proper training to patients and/or caregivers on how to prepare and administer AIMOVIG using the single-dose prefilled autoinjector or single-dose prefilled syringe, including aseptic technique [see Instructions for Use] : Prior to subcutaneous administration, allow AIMOVIG to sit at room temperature for at least 30 minutes protected from direct sunlight [see How Supplied/Storage and Handling ]
• This is important for administering the entire dose and helps minimize discomfort
• Do not warm by using a heat source such as hot water or a microwave
• Do not shake the product
• Inspect visually for particulate matter and discoloration prior to administration [see Dosage Forms and Strengths ]
• Do not use if the solution is cloudy or discolored or contains flakes or particles. …

AIMOVIG is a sterile, clear to opalescent, colorless to light yellow solution available as follows: Injection: 70 mg/mL in a single-dose prefilled SureClick ® autoinjector Injection: 140 mg/mL in a single-dose prefilled SureClick ® autoinjector Injection: 70 mg/mL in a single-dose prefilled syringe Injection: 140 mg/mL in a single-dose prefilled syringe Injection: 70 mg/mL solution in a single-dos …

• Safety and effectiveness
• In pediatric patients have not been established

Clinical studies of AIMOVIG did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Information on Preparation and Administration Provide guidance to patients and caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-dose prefilled autoinjector or single-dose prefilled syringe [see Dosage and Administration ]
• Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use AIMOVIG
• Advise patients to let AIMOVIG sit at room temperature for at least 30 minutes prior to administration [see Dosage and Administration ] . …

• AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients
• Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ]
• AIMOVIG is contraindicated in patients with serious hypersensitivity to erenumab-aooe or to any of the excipients

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of AIMOVIG and initiate appropriate therapy. Hypersensitivity reactions can occur within hours to more than one week after administration. ( 5.1 ) Constipation with Serious Complications: Serious complications of constipation may occur. ( 5.2 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.3 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. ( 5.4 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including rash, angioedema, and anaphylaxis, have been reported with AIMOVIG in postmarketing experience. …

The following serious adverse reactions are described below and elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Constipation with Serious Complications [see Warnings and Precautions (5.2) ] Hypertension [see Warnings and Precautions (5.3) ] Raynaud's Phenomenon [see Warnings and Precautions (5.4) ] The most common adverse reactions in AIMOVIG clinical studies (occurring in at least 3% of treated patients and more often than placebo) are injection site reactions and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AIMOVIG during pregnancy. Patients should be encouraged to enroll by calling 1-833-244-4083 or visiting https://www.genesispregnancyregistry.com/. Risk Summary There are no adequate data on the developmental risk associated with the use of AIMOVIG in pregnant women. …

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. If removed from the refrigerator, AIMOVIG should be kept at room temperature (up to 25°C [77°F]) in the original carton and must be used w …

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.