Xolar, lyophilizate 150 mg

Treatment of persistent atopic bronchial asthma of moderate to severe severity with symptoms insufficiently controlled by use of GCS in patients 12 years and older.

Active ingredient

Composition

1 vial contains:

the active ingredient:

omalizumab 150 mg,

excipients:

sucrose,

L-histidine,

L-histidine hydrochloride monohydrate,

polysorbate 20;

solvent:

water for injection – 2 ml

How to take, the dosage

The drug is administered by injection. The dose of Xolar and the frequency of administration are based on the baseline IgE concentration (IU/ml) measured before treatment and the patient’s body weight (kg).

Depending on these parameters, the recommended dose of the drug is 150 to 375 mg once every 2 or 4 weeks.

Interaction

Since cytochrome P450 enzymes, energy release system mechanisms (efflux pumps) and protein binding do not play a role in omalizumab clearance, Xolar has little potential for drug interactions with other drugs.

There have been no specific studies on the interaction of Xolar with medications, including vaccines.
Interaction of Xolar with medications used to treat bronchial asthma is unlikely.

In clinical studies Xolar was widely used in combination with inhaled and oral GCS, inhaled beta-agonists of short and long action, leukotriene derivatives, theophylline and antihistamines. The above drugs do not affect the safety of Xolar.

The data on the use of Xolar in combination with specific immunotherapy (hypersensitizing therapy) are currently limited.

Special Instructions

Caution should be exercised when using Xolar in patients with hepatic and/or renal dysfunction, with autoimmune diseases or diseases associated with the accumulation of immune complexes.

When using Xolar, as with any other protein-containing drugs, local or systemic allergic reactions, including anaphylactic reactions, may occur. Therefore, it is necessary to prepare in advance the appropriate resuscitation equipment and medications necessary to control hypersensitivity reactions before Xolar is administered. Patients should be informed about the possibility of developing anaphylactic reactions and appropriate medical monitoring of patients should be ensured.

Patients with diabetes mellitus, glucose-galactose malabsorption syndrome, fructose intolerance or sucrose-isomaltase deficiency should be cautious when using the drug. The sucrose content in 1 dose of Xolar (150 mg) is 108 mg.

As with all humanized monoclonal antibodies – recombinant DNA derivatives, antibodies to omalizumab may form in rare cases.

The drug should not be used to treat acute attacks of bronchial asthma, acute bronchospasm or asthmatic status.
In patients with allergic diseases other than bronchial asthma, the safety and effectiveness of the drug have not been established.

The use of Xolar has not been studied in patients with elevated Ig E syndrome, with allergic bronchopulmonary aspergillosis, for prevention of anaphylactic reactions, in atopic dermatitis, allergic rhinitis or in food allergies.

Impact on driving and operating machinery

Patients who have dizziness or other CNS disturbances while using Xolar should refrain from driving or operating machinery while the drug is in use.

Contraindications

Hypersensitivity to omalizumab or any other component of Xolar.

Side effects

The most common adverse events with Xolar are injection site reactions including pain, edema, erythema and itching at the injection site, and headaches.

The majority of adverse events were mild to moderate in severity. The incidence of adverse events possibly related to the use of the drug was estimated as follows: frequently – ≥1/100, but

Infections and invasions: rarely – helminth infections.

Immune system disorders: rare – anaphylactic reactions and other allergic conditions. In clinical trials the incidence of all allergic reactions in the group of patients receiving Xolar and in the control group was similar.

CNS and peripheral nervous system disorders: often – headache; sometimes – dizziness, somnolence, paresthesia, syncopal conditions.

Cardiovascular system disorders: sometimes – postural hypotension, hot flashes.

Respiratory system disorders: sometimes – pharyngitis, cough, allergic bronchospasm.

The digestive system: sometimes – nausea, diarrhea, dyspeptic phenomena

Dermatological reactions: sometimes – urticaria, rash, itching, photosensitization.

With the body in general: sometimes – weight gain, fatigue, swollen hands, flu-like condition.

Local reactions: often pain, erythema, itching, swelling at the injection site.

The incidence of adverse reactions in the group of patients receiving Xolar and in the control group of patients taking placebo was similar.

Malignization. In clinical trials, the incidence of malignancies was different in the group of patients receiving Xolar and in the control group. In both groups, the study and control groups, the incidence of malignancy was assessed by the frequency of

Changes in blood platelet counts. In clinical trials, several patients with Xolar had decreased platelet counts below normal, which was not accompanied by bleeding or decreased hemoglobin counts.

The clinical studies did not show a permanent decrease in platelet counts.

Data from other laboratory studies. No significant changes in laboratory values were found in clinical studies.

Overdose

No cases of Xolar overdose have been reported to date.

The maximum tolerated dose of Xolar has not yet been determined.

The highest cumulative dose of the drug (44,000 mg) has not had any severe acute adverse events when administered to patients for 20 weeks.

Pregnancy use

Special studies on the use of omalizumab in pregnant women have not been conducted.

There have been no direct or indirect negative effects of the drug on the course of pregnancy, embryo and fetal development, the course of labor and development of newborns in experimental studies.

IgG molecules are known to penetrate the placental barrier.

The use of Xolar in pregnancy is possible only when the expected benefit to the mother exceeds the potential risk to the fetus.

It is not known whether omalizumab is excreted with breast milk in humans.

Human IgG is excreted with breast milk.

Given the potential for excretion with breast milk and the possible negative effects of omalizumab on the fetus, caution should be exercised when prescribing Xolar during breastfeeding.