Dr. Ahmed
Cinqair (Reslizumab) Injection is an intravenous formulation of a biological medicine that has been FDA approved for the treatment of adults (18 years of age or older) for the treatment of severe asthma.
It is only indicated for those patients who have severe allergic asthma that requires additional maintenance medications.
It is important to note that Cinqair (Reslizumab) Injection is not indicated for the treatment of acute severe asthma, an acute severe attack of asthma, or status asthmaticus.
In addition, It is only indicated for the eosinophilic variant of asthma. It should not be used to treat other eosinophilic conditions.
Other biologics used to treat asthma are:
Cinqair (Reslizumab) Injection Dosage formulations:
It is available as a 100 mg/10 ml (10 mg/ml) vial that is clear to slightly yellowish. It is recommended only for intravenous infusion. Administration as an IV push or bolus should be avoided [Ref].
Cinqair (Reslizumab) Injection Dose:
The recommended dose is 3 mg/kg intravenously every four weeks in slow intravenous infusion over 30 to 50 minutes.
The rate of infusion should be kept at a minimum to look for any allergic or anaphylactic reactions.
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How to prepare the Cinqair (Reslizumab) Infusion:
Remove the injection from the refrigerator. Inspect the solution of the injection for any discoloration or particulate matter. The injection should not be shaken before preparing the infusion.
The solution should look clear or slightly pale. Also, check the drug expiry label before making the infusion.
Calculate your dose before making the syringe. The dose is calculated based on the actual body weight as 3 mg/kg. For example, a 60 kgs person requires 3 x 60 = 180 mg of the total dose.
One vial contains 100 mg per 10 ml. So each ml contains 10 mg. To withdraw 180 mg, you need 18 ml of the solution. We need two vials of 100 mg/10 ml each.
We’ll take 10 ml (100 mg) from one vial and 8 ml (80 mg) from the other vial to make a total of 180 mg infusion.
Mix the drug with 50 ml of 0.9% sodium chloride (0.9% Saline) in a bag. Invert the bag but do not shake the bag. Also, Cinqair should not be mixed with other drugs or medicines.
After preparing the infusion, immediately infuse it in over 30 to 50 minutes. If for some reason, the infusion is delayed, it can be stored at room temperature not exceeding 25C or in the refrigerator at 2 C to 8 C (36 F to 46 F) for a maximum of 16 hours.
To manage any untoward reactions, especially severe anaphylaxis, it is best to administer Cinqair (Reslizumab) Injection in a hospital setting where facilities to resuscitate and manage anaphylaxis are available.
The infusion should be initiated immediately after preparation. However, if delayed and the infusion is kept in a refrigerator, it should be allowed at room temperature before the infusion. Avoid infusing it at lower than room temperature.
The infusion time may vary depending on the total amount of drug being given. Avoid combining it with other medications or preparing it in solutions other than 0.9% saline.
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During the infusion, the patients should be observed for any sort of allergic reactions or anaphylaxis. In case any allergic reaction is observed, the treatment should be immediately discontinued.
In severe cases, the patient may need corticosteroids, antihistamines, fluids, and even adrenaline to manage severe anaphylaxis and angioedema.
After the infusion is over, flush the tubings with 0.9% saline to ensure all the drug has been infused.
Dose in kidney and Liver diseases:
Clinical studies have not been conducted on patients with liver or renal impairment. The drug’s pharmacokinetics is not affected by a change in renal or liver impairment.
Dose adjustment in these conditions is probably not necessary.
Dose in pregnancy and breastfeeding:
Human IgG antibodies can cross the placental barrier and can also be detected in breastmilk. In animal studies, infusing Cinqair during the period of organogenesis did not result in any teratogenic effects.
Uncontrolled asthma, on the other hand, may be associated with maternal preeclampsia, and small for gestational age.
The drug can enter the breastmilk. The effects of the drug on the breastfeeding infant are not known. Although gut enzymes will degrade the drug and systemic exposure is not possible.
Still, one should be cautious when administering it to a breastfeeding mother considering the benefits and harms of the drug.
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Contraindications and warnings:
Reslizumab is not approved for the treatment of moderate to severe allergic asthma in patients who are younger than 18 years of age.
Allergic reactions:
Cinqair (Reslizumab) Injection is contraindicated if a person is allergic to it. It should be avoided in patients who have had an allergic reaction to the drug in the past, especially those with a severe anaphylactic reaction.
Anaphylaxis may occur in patients as soon as 20 minutes after the infusion is started. It may be much earlier in patients who are getting the drug for the second time.
The clinical signs and symptoms of anaphylaxis should be immediately identified. These include itching, hives, redness, lips and face swelling, shortness of breath, wheezing, vomiting, and low blood pressure.
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In case of anaphylaxis, the infusion should be immediately stopped. Patients should be observed for evidence of anaphylaxis.
In severe cases, appropriate treatment such as administering intravenous fluids, corticosteroids, antihistamines, and adrenaline may be required to treat the acute symptoms of anaphylaxis. Patients may require admission in a high-dependency or critical care unit.
Rechallenge with Cinqair (Reslizumab) Injection should be avoided in the future.
Acute severe asthma:
In cases of acute severe asthma or status asthmaticus, treatment with Cinqair (Reslizumab) is not recommended. It is not indicated in the treatment of severe bronchospasm or status asthmatics.
Corticosteroids withdrawal:
Abrupt withdrawal of corticosteroids should be avoided. This is particularly true for patients who are on high doses of corticosteroids for a longer duration or on higher doses.
Slow tapering may be done once the patient is clinically very stable but only after prior recommendations by a pulmonologist or a healthcare advisor.
Sometimes, in patients who reduce the dose of corticosteroids, other medical conditions may develop. This is because corticosteroid withdrawal leads to the unmasking of the underlying inflammatory or allergic conditions.
Helminthic (Parasitic) infections:
Eosinophils are required to clear parasitic and helminthic infections from the body. Since Cinqair depletes all the eosinophils, it may be difficult to get rid of worms and other parasitic infections.
It is recommended to screen for and treat any concomitant helminthic infections before treatment initiation.
If during the treatment, patients develop a helminthic infection, a trial of antihelminthic drugs may be given before discontinuing the treatment.
However, if the infection is resistant to the drugs, Cinqair treatment may be temporarily discontinued.
Risk of cancers:
The risk of malignancy was double in clinical trials. Compared to the placebo, more patients in the Cinqair treatment group developed a neoplasm (0.6% in the Cinqair group vs 0.3% in the placebo group).
No specific cancer type was observed. However, most patients who developed the neoplasm were diagnosed within 6 months of treatment initiation.
Side effects of Cinqair (Reslizumab) Injection:
Muscles and skeletal side effects were more common in the Cinqair (Reslizumab) group in clinical trials compared to the placebo.
Muscuoloskeletal side effects included:
Myalgias (1% vs 0.5%)
Elevated CK (Creatine kinase) (14% vs 9%)
CK elevation exceeding 10 times the upper limits of normal was observed in 0.8% vs 0.4%. Symptomatic patients with CK greater than 10 ULN resulted in treatment discontinuation.
Skeletal and muscle-related side effects were commonly observed on the day of infusion (2.2% vs 1.5%). These side effects included:
- Chest pain
- Neck pain
- Muscle spasms
- Extremity pain
- Fatigue and
- Joint pain
Antibody formation:
In clinical trials, antibodies against Cinqair were observed in 5.4% to 4.8% of the patients. However, these antibodies did not alter the efficacy or safety of the drug.
Drug Interactions:
The manufacturer has not mentioned any drug interactions.
Mechanism of action (MOA) of Reslizumab (Cinqair):
Cinqair (Reslizumab) is a humanized monoclonal antibody of the IgG4κ type. It inhibits the binding of IL-5 to its receptors.
Since IL-5 is the main driving factor that promotes the differentiation, growth, and activation of eosinophils, inhibiting it blunts the inflammatory response that occurs in patients with asthma.
Half-life elimination:
- It has a half-life of about 24 days.
Metabolism:
- It undergoes proteolytic degradation into aminoacids.
Price of Cinqair injection:
The price of one injection of 100 mg/10 ml is about $ 1000 USD.
