Ajovy From Teva Pharmaceuticals, Inc

Teva Pharmaceuticals Inc has released Ajovy (fremanezumab-vfrm) injection in the United States, following approval by the FDA for preventive treatment of migraines in adults.¹ More than 36 million Americans are affected by migraines, up to 40% of whom may be candidates for preventive treatment to decrease their migraine days per month.²

PHARMACOLOGY AND PHARMACOKINETICS

Ajovy is a humanized monoclonal antibody. It binds to calcitonin gene-related peptide ligand and blocks its binding to the receptor. Ajovy reaches maximum plasma concentrations 5 to 7 days after a single subcutaneous (SC) dose. Steady-state concentrations are achieved after about 6 months of monthly or quarterly dosing. The elimination half-life is about 31 days. The pharmacokinetics of Ajovy are not affected by age, race, sex, or weight and are not expected to be affected by hepatic or renal impairment.¹

DOSAGE AND ADMINISTRATION

Ajovy should be administered subcutaneously in the abdomen, thigh, or upper arm as either 225 mg monthly or 675 mg every 3 months. It is supplied as a single-dose prefilled syringe that contains 225 mg. The 675-mg dose should be administered as 3 consecutive SC injections of 225 mg each.¹ It may be given by a caregiver or health care provider or self-administered.

CLINICAL TRIALS

The efficacy of Ajovy as a preventive treatment of chronic or episodic migraine was evaluated in 2 double blind, multicenter, placebo-controlled, randomized studies. Study 1 lasted for a treatment period of 3 months and consisted of adults with a history of episodic migraine who experienced fewer than 15 headache days per month. Participants were randomized to receive SC injections of either Ajovy 675 mg every 3 months, Ajovy 225 mg monthly, or placebo monthly. The researchers concluded that both Ajovy groups demonstrated a statistically significant decrease in their monthly average migraine days. Statistically significant changes were also demonstrated in the proportion of patients reaching at least a 50% reduction in their monthly average migraine days and the average days that any acute headache medication was used.

Study 2 lasted for a treatment period of 3 months and consisted of adults with a history of chronic migraine who experienced 15 or more headache days per month. Participants were randomized to receive SC injections of either Ajovy 675 mg as a starting dose, followed by 225 mg monthly, 675 mg every 3 months, or placebo monthly. At the study’s end, both the monthly and quarterly Ajovy groups demonstrated a statistically significant decrease in their monthly average migraine days of at least moderate severity. There also was a significant reduction in the proportion of patients reaching at least a 50% reduction in their monthly average number of migraine days per month, as well as in the average number of days that any acute headache medication was used.^1,2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

The use of Ajovy is contraindicated in patients with a serious hypersensitivity to the medication or any of its components. Reactions such as drug hypersensitivity, pruritus, rash, and urticaria have occurred during clinical trials with Ajovy. Most reactions were mild to moderate, but some resulted in discontinuation of treatment or required treatment with corticosteroids. Most reactions occurred within hours to 1 month after administration. If a hypersensitivity reaction occurs, consider discontinuation of Ajovy and initiate appropriate treatment.

Adequate data are not available regarding the developmental risk associated with the use of Ajovy during pregnancy. Its long half-life should be taken into consideration for women who are pregnant or plan to become pregnant while using the medication. There also are no data on the presence of Ajovy in human breastmilk, the effects on an infant who is breastfed by a woman using Ajovy, or the effects on breastmilk production during treatment with Ajovy. The effectiveness and safety of treatment with Ajovy in pediatric patients have not been established.

The most common adverse effects (≥5% and greater than placebo) are injection-site reactions.¹

Monica Holmberg, PharmD, BCPS, earned her PharmD at the University of Connecticut in Storrs and completed an ambulatory care residency at the Phoenix VA Health Care System in Arizona. Her practice has also included pediatrics and inpatient mental health. She lives in Phoenix.

REFERENCES

• Ajovy [prescribing information]. North Wales, PA: Teva Pharmaceuticals Inc; 2019. ajovy.com/globalassets/ajovy/ajovy-pi.pdf. Accessed June 2, 2019.
• Teva announces U.S. approval of Ajovy (fremanezumab-vfrm) injection, the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults [news release]. Jerusalem, Israel: Teva, USA; September 15, 2018. tevausa.com/news-and-media/press-releases/adding-multimedia-teva-announces-u.s.-approval-of-ajovytm-fremanezumab-vfrm-injection-the-first-a/. Accessed June 2, 2019.