Ajovy Syringe (fremanezumab-vfrm)

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Fremanezumab-vfrm is administered by subcutaneous injection only. Fremanezumab-vfrm injection is commercially available in single-use prefilled syringes and auto-injectors containing 225 mg of the drug in 1.5 mL of solution. The drug may be administered by healthcare professionals, patients >=13 years of age, and/or caregivers. A healthcare professional or adult caregiver must administer the drug to pediatric patients 6-12 years of age.

Prior to use, patients and/or caregivers should receive proper training on how to prepare and administer fremanezumab-vfrm using the single-use prefilled syringes, including aseptic technique. The manufacturer's labeling should be consulted for detailed instructions regarding subcutaneous administration of the drug using the prefilled syringes or auto-injectors.

Fremanezumab-vfrm should be administered subcutaneously into the abdomen, anterior thigh, or back of the upper arm; injections within 2 inches of the navel, knee, or groin should be avoided. Multiple injections of the drug (i.e., to administer a 675-mg dose) may be administered at the same body site, but not at the exact location of the previous injection. Fremanezumab-vfrm should not be administered concomitantly with other parenteral drugs at the same injection site. Injection into areas where the skin is tender, bruised, erythematous, or indurated should be avoided.

Prefilled syringes and auto-injectors of fremanezumab-vfrm should be stored at 2-8degreesC in the original outer carton to protect from light. The syringes and auto-injectors may be stored at room temperature up to 30degreesC in the original carton for up to 7 days; the syringes and auto-injectors should not be returned to the refrigerator after storage at room temperature. If the syringes or auto-injectors are stored at room temperature for 7 days or more, they should be discarded. The prefilled syringes and auto-injectors should not be frozen, shaken, or exposed to extreme heat or direct sunlight.

Prior to subcutaneous administration, prefilled syringes and auto-injectors of fremanezumab-vfrm should be removed from the refrigerator and allowed to sit at room temperature for 30 minutes protected from direct sunlight. Do not warm the syringes or auto-injectors by using a heat source (e.g., microwave, hot water). Prior to administration, the solution should be inspected visually for particulate matter and discoloration; the syringe or auto-injector should not be used if the solution is cloudy or discolored or contains particles. The prefilled syringes and auto-injectors are intended for single use only and should be discarded after use.

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Formal drug interaction studies with fremanezumab have not been conducted to date. The risk of clinically important drug interactions with the drug appears to be minimal. Fremanezumab is not metabolized by cytochrome P-450 (CYP) enzymes. In addition, fremanezumab, a monoclonal antibody, is unlikely to affect drug-metabolizing enzymes or drug transport systems. 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 fremanezumab or to any excipients in the formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Constipation
• Gastrointestinal hypomotility
• Hypertension
• Raynaud's phenomenon

The most common adverse reactions (>=5% and incidence greater than placebo) with fremanezumab are injection site reactions.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Constipation
• Hypersensitivity drug reaction

More Frequent

• Injection site sequelae

Rare or Very Rare

• Hypertension
• Pruritus of skin
• Raynaud's phenomenon
• Skin rash
• Urticaria

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The safety and efficacy of fremanezumab were established for the preventive treatment of episodic migraine in pediatric patients 6-17 years of age weighing >=45 kg in an adequate and well-controlled study. The safety and efficacy profile of the drug in these patients was similar to that observed in clinical trials of adults with migraine.

Fremanezumab is not approved for pediatric patients who weigh <45 kg due to lack of an appropriate strength presentation. Fremanezumab is also not approved for use in pediatric patients <6 years of age and the safety and efficacy of the drug have not been established for the preventive treatment of chronic migraine in pediatric patients.

The Pediatric and Adolescent Headache special interest group of the American Headache Society (AHS) recommends that CGRP antagonists (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 nonpharmacologic 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 CGRP antagonists 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 fremanezumab in pregnant women. The manufacturer states that the long elimination half-life of fremanezumab should be considered if the drug is used in women who are pregnant or plan to become pregnant during therapy. Animal studies in pregnant rats and rabbits administered fremanezumab subcutaneously at dosages resulting in systemic exposures up to approximately 2-3 times the exposure from the maximum recommended human dosage (675 mg) did not adversely affect the development of 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 during pregnancy.

A registry that monitors outcomes in women exposed to fremanezumab during pregnancy exists; enrollment in the registry can occur by calling 833-927-2605 or visiting https://www.tevamigrainepregnancyregistry.com.

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

The manufacturer makes no specific dosage recommendations for geriatric patients.

Clinical trials of fremanezumab did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger adults.