Aimovig Autoinjector (erenumab-aooe)

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Erenumab-aooe is administered by subcutaneous injection once monthly. The drug is commercially available in single-dose prefilled auto-injectors (i.e., injection pens) and single-dose prefilled syringes. Both the auto-injectors and syringes are intended for patient self-administration.

Prior to use, patients and/or caregivers should receive proper training on how to prepare and administer erenumab-aooe using the prefilled auto-injectors and syringes. Consult the manufacturer's labeling for detailed instructions regarding subcutaneous administration of the drug.

Administer subcutaneous injections into the abdomen, thigh, or outer area of the upper arm; avoid injections within 2 inches of the navel. Use the upper arm as an injection site if someone other than the patient (e.g., caregiver, healthcare professional) is administering the injection. Avoid injection into areas where the skin is tender, bruised, erythematous, or indurated.

Store prefilled auto-injectors and syringes of erenumab-aooe at 2-8degreesC in the original carton to protect the drug from light until time of use. The auto-injectors and syringes may be stored at room temperature up to 25degreesC in the original carton for up to 7 days. Discard the drug if it is stored for more than 7 days at room temperature. Do not freeze or shake the prefilled auto-injectors and syringes.

Prior to subcutaneous administration, remove the prefilled auto-injectors and syringes from their carton and allow them to sit at room temperature for at least 30 minutes; avoid exposure to direct sunlight. The auto-injectors and syringes should not be warmed by using a heat source (e.g., microwave, hot water). Prior to administration, visually inspect the solution for particulate matter and discoloration; do not use the drug if it is cloudy or discolored or contains flakes or particles. The prefilled auto-injectors and syringes are intended for single-use only; discard any unused portions.

No dosing information is available for this tab.

The risk of clinically important drug interactions with erenumab appears to be minimal. Erenumab is not metabolized by cytochrome P-450 (CYP) isoenzymes. In addition, erenumab is unlikely to have an effect on drug-metabolizing enzymes or drug transporters. Therefore, pharmacokinetic interactions with drugs affecting or metabolized by CYP enzymes or substrates of various drug transport systems are not expected.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

*Serious hypersensitivity to erenumab-aooe or any excipients in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Hypertension
• Raynaud's phenomenon

Adverse effects reported in >=3% of patients receiving erenumab-aooe for migraine in placebo-controlled clinical studies and more frequently than with placebo include injection site reactions (e.g., pain, erythema, pruritus) and constipation.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Hypersensitivity drug reaction
• Hypertension

More Frequent

• Constipation
• Injection site sequelae

Less Frequent

• Bronchitis
• Cough
• Cramps
• Diarrhea
• Dizziness
• Fatigue
• Influenza
• Injection site erythema
• Injection site pain
• Insomnia
• Migraine
• Muscle spasm
• Nausea
• Pruritus of skin
• Sinusitis
• Upper respiratory infection
• Urinary tract infection
• Vomiting

Rare or Very Rare

• Alopecia
• Raynaud's phenomenon
• Skin rash
• Stomatitis

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The manufacturer states that the safety and efficacy of erenumab-aooe have not been established in pediatric patients <18 years of age.

Pending further clinical experience with the use of anti-CGRP monoclonal antibodies in pediatric patients, the Pediatric and Adolescent Headache special interest group of the American Headache Society (AHS) recommends that anti-CGRP monoclonal antibodies (e.g., erenumab, fremanezumab, galcanezumab) should be considered mainly for use in postpubertal adolescents+ with relatively frequent migraines (i.e., 8 or more headache days per month) who have moderate to severe disability associated with migraine (e.g., PedMIDAS score of 30 or more) and in whom at least 2 preventive therapies (including pharmacologic and non-pharmacologic therapies and dietary supplements) have failed. For younger pediatric patients+ with severe chronic migraine that is refractory to multiple preventive therapies, these experts recommend that anti-CGRP monoclonal antibodies be considered only in carefully selected patients with close monitoring (e.g., pubertal status, bone health, linear growth, weight, body mass index (BMI), infectious complications).

There are no adequate data to date on the developmental risk associated with the use of erenumab in pregnant women. Animal studies in pregnant monkeys administered erenumab-aooe subcutaneously at dosages resulting in systemic exposures approximately 20 times the exposure from the maximum recommended human dosage (140 mg monthly) throughout gestation have not revealed evidence of harm to the offspring.

The estimated rates of major birth defects and miscarriage among deliveries to women with migraine (2.2-2.9 and 17%, respectively) are similar to rates reported in women without migraine. Clinicians should be aware that published data suggest that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

A pregnancy registry that monitors outcomes in women exposed to erenumab during pregnancy has been established. Patients may be enrolled by calling 833-244-4083 or visiting https://www.genesispregnancyregistry.com.

It is not known whether erenumab is distributed into human milk. The effects of the drug on the breast-fed infant or on milk production also are unknown. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for erenumab and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Select dosage carefully in geriatric patients, usually starting at the low end of the dosage range.

Clinical trials of erenumab did not include sufficient numbers of patients >=65 years of age to determine whether they respond differently than younger adults. The manufacturer recommends cautious dosage selection in geriatric patients, usually starting at the low end of the dosage range, taking into consideration the greater frequency of decreased hepatic, renal, and/or cardiac function and other concomitant disease and drug therapy in this population.