Emgality Pen (galcanezumab-gnlm)

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Galcanezumab-gnlm is administered by subcutaneous injection only. Galcanezumab-gnlm injection is commercially available in single-dose prefilled auto-injectors (i.e., injection pens), which contain 120 mg of the drug, and single-dose prefilled syringes, which contain either 100 or 120 mg of the drug. Both formulations of the drug are intended for patient self-administration.

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

Galcanezumab-gnlm should be administered subcutaneously into the abdomen, anterior thigh, back of the upper arm, or buttocks; injections within 2 inches of the navel, knee, or groin should be avoided. The back of the upper arm or buttocks may be used if someone other than the patient is administering the injection (e.g., caregiver, healthcare professional). Multiple injections of the drug (i.e., the initial loading dose for preventive treatment of migraine consisting of 2 injections and the dose for treatment of episodic cluster headache consisting of 3 injections) may be administered at separate locations at the same body site. Injection into areas where the skin is tender, bruised, erythematous, or indurated should be avoided.

Prefilled auto-injectors and syringes of galcanezumab-gnlm should be stored at 2-8degreesC in the original carton to protect from light until time of use. These formulations of the drug may be stored at room temperature up to 30degreesC in the original carton for up to 7 days; they should not be returned to the refrigerator after storage at room temperature for longer than 1 hour. The prefilled auto-injectors and syringes should not be frozen or shaken. If the auto-injectors or syringes are stored at room temperature for more than 7 days or are frozen or shaken vigorously (i.e., shaking beyond the normal vibration, shaking, or bumping that occurs during typical transport activities), they should be discarded. If galcanezumab-gnlm prefilled auto-injectors or syringes are exposed to conditions outside of the recommended storage and handling conditions, the manufacturer may be able to provide further information regarding stability and product quality assessment; patients or healthcare professionals may contact the manufacturer by calling 800-545-5979.

Prior to subcutaneous administration, prefilled auto-injectors and syringes of galcanezumab-gnlm should be removed from their carton and allowed to sit at room temperature for 30 minutes; exposure to direct sunlight should be avoided. The auto-injectors and syringes should not be warmed 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 prefilled auto-injector or syringe should not be used if the solution is cloudy or discolored or contains particles. The prefilled auto-injectors and syringes are intended for single use only and should be discarded after use.

No dosing information is available for this tab.

Formal drug interaction studies with galcanezumab have not been conducted to date. The risk of clinically important drug interactions with galcanezumab appears to be minimal. Galcanezumab is not metabolized by cytochrome P-450 (CYP) enzymes. In addition galcanezumab, a monoclonal antibody, is not likely to be affected by 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 galcanezumab or to any of the 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

Adverse effects reported in 2% or more of patients receiving galcanezumab for the preventive treatment of migraine in clinical studies and at least 2% more frequently than with placebo include injection site reactions (e.g., pain, erythema, pruritus, swelling), which were usually mild to moderate in severity and resolved within a few days to 2 weeks.

The tolerability profile of galcanezumab in patients with episodic cluster headache is consistent with the tolerability profile observed in migraine patients.

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Constipation
• Hypersensitivity drug reaction

More Frequent

• Injection site sequelae

Rare or Very Rare

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

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Safety and efficacy of galcanezumab have not been established in pediatric patients. A clinical study to evaluate the efficacy and safety of galcanezumab in the preventive treatment of episodic migraine in pediatric patients 6-17 years of age+ is currently under way.

Pending further clinical experience with the use of anti-calcitonin gene-related peptide (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., Pediatric Migraine Disability Assessment (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 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 on the developmental risk associated with the use of galcanezumab in pregnant females. Animal studies in pregnant rats and rabbits administered galcanezumab subcutaneously throughout the period of organogenesis or to rats throughout pregnancy at systemic exposures greater than those expected clinically have not revealed evidence of harm to the offspring.

The estimated rate 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 females with migraine may be at an increased risk of vascular complications such as preeclampsia during pregnancy. The long elimination half-life of galcanezumab should be considered if the drug is used in females who are pregnant or plan to become pregnant during therapy.

There is a pregnancy exposure registry that monitors fetal outcomes in females exposed to galcanezumab during pregnancy. Healthcare providers are encouraged to register patients by calling the pregnancy exposure registry at 833-464-4724 or by visiting https://www.migrainepregnancyregistry.com.

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

Insufficient data in adults >65 years of age to make specific dosage recommendations.

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