Cinqair

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cinqair there are no specific foods that you must exclude from your diet when receiving this medication.

• You will be given Cinqair by a healthcare provider using a needle placed in a vein (intravenous infusion) one time every four weeks. It will take about 20 to 50 minutes to receive the full dose of Cinqair.

Antiasthmatic agent; a recombinant DNA-derived humanized interleukin-5 (IL-5) receptor antagonist monoclonal antibody and IgG4 kappa immunoglobulin.1 6

Asthma

Adjunctive maintenance therapy in patients with severe eosinophilic asthma.1 2 3 4

Reduces asthma exacerbation rate and improves FEV1 from baseline.1 2 3 4

Eosinophilic phenotype (i.e., eosinophilic asthma) generally characterized by blood and sputum eosinophilia, eosinophilic inflammation, recurrent asthma exacerbations, and, frequently, responsiveness to corticosteroids.6 8 9 10

Not indicated for treatment of other eosinophilic conditions.1

Not indicated for relief of acute bronchospasm or status asthmaticus.1

• Recombinant DNA-derived humanized interleukin-5 (IL-5) receptor antagonist monoclonal antibody and IgG4 kappa immunoglobulin.1

• Inhibits binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface.1

• Blocks IL-5 signaling, thereby interfering with growth, differentiation, recruitment, activation, and survival of eosinophils.1

• It is used to treat asthma.
• Do not use Cinqair to treat an asthma attack. Use a rescue inhaler. Talk with your doctor.

Use Cinqair as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Throat pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Pregnancy

Risk Summary

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as reslizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy. Reslizumab has a long half-life [see Clinical Pharmacology (12.3)]. This should be taken into consideration.

In animal reproduction studies, there was no evidence of embryo-fetal adverse developmental effects with intravenous administration of reslizumab during organogenesis to pregnant mice and rabbits at doses that produced exposures up to approximately 6 times the exposure at the maximum recommended human dose (MRHD) in mice and approximately 17 times the exposure at the MRHD in rabbits [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo-Fetal Risk

In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

Data

Animal Data

In 2 separate embryo-fetal development studies, pregnant mice and rabbits received a single reslizumab dose during the period of organogenesis at 2, 10, and 50 mg/kg (0.4, 1.5, and 6 times the exposures achieved at the MRHD in mice on an AUC basis and 0.67, 3.3, and 17 times the exposures achieved at the MRHD in rabbits on a mg/kg basis). Reslizumab was not teratogenic in mice or rabbits. Embryo-fetal development of interleukin-5 (IL-5) deficient mice has been reported to be generally unaffected relative to wild-type mice.

In a prenatal and postnatal development study, pregnant CD-1 mice received reslizumab during organogenesis on gestation days 6 and 18 and on postnatal day 14 at 10 or 50 mg/kg (1.5 and 6 times the exposures achieved at the MRHD on an AUC basis). Reslizumab did not have any effects on fetal development up to approximately 4 months after birth. Reslizumab crossed the placenta of pregnant mice. Serum concentrations in pups were approximately 6-8% of those in the dams (parental female mice) on postnatal day 14.

Lactation

Risk Summary

It is not known whether reslizumab is present in human milk, and the effects of reslizumab on the breast fed infant and on milk production are not known. However, human IgG is known to be present in human milk. Reslizumab was present in the milk of lactating mice following dosing during pregnancy [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cinqair and any potential adverse effects on the breast-fed child from Cinqair or the underlying maternal condition.

Data

Reslizumab was excreted in milk of lactating CD-1 mice that received reslizumab at 10 or 50 mg/kg (1.5 and 6 times the exposures achieved at the MRHD on an AUC basis) during pregnancy on gestation days 6 and 18 and on postnatal day 14. Levels of reslizumab in milk were approximately 5-7% of maternal serum concentrations.

Pediatric Use

Cinqair is not indicated for use in pediatric patients less than 18 years of age. The safety and effectiveness in pediatric patients (aged 17 years and younger) have not been established.

Cinqair was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week exacerbation studies and one 16-week lung function study. In the exacerbation studies, patients were required to have at least 1 asthma exacerbation requiring systemic corticosteroid use in the year prior to study entry. In these studies, the asthma exacerbation rate was higher in adolescent patients treated with Cinqair than placebo (Cinqair n=14, rate 2.86, 95% CI [1.02 to 8.09] and placebo n=11, rate 1.37, 95% CI [0.57 to 3.28]: rate ratio 2.09, 95% CI [0.82 to 5.36]).

Geriatric Use

Cinqair was evaluated in 122 patients aged 65 years and older with asthma in two 52-week exacerbation studies and two 16-week lung function studies. No overall differences in safety or effectiveness were observed between these patients and younger patients. Based on available data, no adjustment of the dosage of Cinqair in geriatric patients is necessary.

Single doses of up to 732 mg have been administered intravenously to subjects in clinical trials without evidence of dose-related toxicities.

There is no specific treatment for an overdose with Cinqair. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

Cinqair (reslizumab) injection, 100 mg/10 mL (10 mg/mL), is supplied as a preservative-free, sterile, clear to slightly hazy/opalescent, colorless to slightly yellow solution in single-use vials. The following packaging configuration is available:

Storage and Stability: Refrigerate at 2 ºC to 8ºC (36°F to 46°F). Do not freeze. Do not shake. Protect the vials from light by storing in the original package until time of use.