Lollair 150mg/1.2ml Novartis treatment powder for allergies and urticaria
Dosage form 1 bottle box
Specifications Omalizumab
Ingredient
| Composition information | Content |
| Omalizumab | 150mg |
Uses
indications
Smolair 150 mg is indicated in the following cases:
An allergic asthma treatment:
Pharmacology
omalizumab is a single -inflated antibody produced by recombinant DNA technology selected with Immunoglobulin E (IgE). Antibodies are an IgG1 Kappa containing human frame areas along with the additional determination areas of an antibody derived from mice associated with IgE.
Patients with asthma due to allergies
The allergic waterfall starts when the IgE is attached to the FC JRI receptor with high affinity on the surface of the moisturizer and alkaline leukocytes are crossed by allergens. This leads to the loss of granular losses of these effects and releases histamine, leucotrien, cytokine and other intermediate substances. These intermediate substances are related to the cause and effect of the physiology of allergic asthma, including airway edema, smooth muscle contraction and changing cell activity associated with inflammation. They also contribute to the signs and symptoms of allergies such as bronchospasm, mucus production, wheezing, shortness of breath, chest tightness, nasal congestion, sneezing, itching, runny nose with itching, watery eyes.
omalizumab is connected to IgE and prevents the attachment of IgE into the FC JRI receptor, thus reducing the amount of free IgE available to activate the allergic process. Treatment of patients with allergies with omalizumab leads to a clearly downstream regulator of the FCεi receptor. Moreover, the release of histamine in vitro from alkaline white blood cells isolated from patients treated with xolair to about 90% after stimulation with an allergic compared to the values before treatment.
Patients with chronic spontaneous urticaria (CSU)
Some hypotheses are given to the pathogenesis of chronic spontaneous urticaria, including thinking that there is autoimmune cause. The autoimmune antibodies for IgE and its receptors, FCεi, have been isolated from the serum of some patients with chronic spontaneous urticaria. These antibodies can activate alkaline leukocytes (baSophil) or masters (mast cells) to release histamine.
A hypothetical about the mechanism of action of omalizumab in chronic spontaneous urticaria is that it reduces the free IgE level in the blood, then in the skin. This reduces the surface IgE receptor density and has thus reduces the downstream signals through the FCεi path, inhibits the activation of cells and responds to inflammation. As a result, the frequency and severity of the symptoms of chronic spontaneous urticaria are reduced. Another assumption is that reducing free IgE leads to rapid reduction and no specific sensitivity of skin moisturizers. Reducing FCεi density can help maintain treatment.
Pharmacokinetics
absorption
After subcutaneous injection, Omalizumab is absorbed with an absolute bioavailability of 62%. The pharmacokinetics of omalizumab linear at doses greater than 0.5 mg/kg.
Distribution
In vitro, Omalizumab forms limited size complexes with IgE. Precipitation complexes and complexes with molecular weight larger than one million Dalton are not observed in vitro and in vivo. Studies on the distribution of tissue in Cynomolgus monkeys show that there is no specific absorption of 125i - Omalizumab by any organ or tissue.
Elimination
The clearance of omalizumab is associated with the IgG clearance as well as the clearance through specific cohesion and formation of complexes with the target, IgE. The elimination of IgG through the liver is due to the degradation in the endothelial grid (RES) of the liver and endothelial cells. The intact IgG is also eliminated through the bile. In studies with mice and monkeys, the omalizumab complex: IgE is excreted due to interaction with the FCγ receptors in the res at the general speed faster than the IgG clearance.
Before taking Lollair 150mg/1.2ml Novartis treatment powder for allergies and urticaria
How to use
The drug is only injected under the skin. Do not intravenously or intramuscularly.
Instructions for use, processing and cancellation
Powder jar and solvent to mix injection solution.
Mixed powder of 150 mg of xolair injection solution is provided in disposable vials and does not contain antibacterial preservatives. The physical and chemical stability of the mixed drug has been shown to be in 8 hours at 2 ° C to 8 ° C and for 4 hours at 30 ° C. From a microbiological point of view, the drug solution should be used immediately after mixing. In case of not immediately used, the drug solution can be used for no more than 8 hours on the condition that the storage is 2 - 8oC or 2 hours at 25 ° C.
Freezing products need 15-20 minutes to dissolve, although in some cases may need longer.
Instructions for preparing xolair for subcutaneous injection
allergies
The appropriate dose and the number of xolair use depends on the original IgE concentration (IU/mL) measured before starting treatment and on the weight (kg). Before starting the drug, patients need to quantify the IgE concentration because any of the total IgE quantitative method in the serum to allocate the dose. Based on these results, the dose of xolair may be needed for each time of 75 - 600 mg divided into 1 to 4 injections. Table 4 is the conversion diagram, table 5 and 6 to determine the dose. For doses of 225, 375 or 525 mg xolair, it is necessary to use a combination of 150 mg xolair with xolair 75 mg.
Patients with initial IgE concentrations or weight in external kg in the table of dose Determination should not be used.
Do not inject more than 150 mg of omalizumab at an injection site in one injection. When the dose is more than 150 mg, the dose should be divided in injection in two or more injection sites.
.
Dosage, monitoring and adjustment time.
In clinical trials, there is a reduction in asthma attacks and reducing the use of emergency drugs, and improving symptoms in the first 16 weeks of treatment. It takes at least 12 weeks of treatment to make a satisfactory evaluation whether the patient responds to the xolair.
xolair needs long -term treatment. Stop drug stops often cause free IgE levels and symptoms to increase again.
The total IgE concentration increases during treatment and remains high until one year after stopping treatment. Therefore, quantifying IgE concentration while treating xolair is not used as a basis for determining the dose. The determination of the dose after stopping treatment has not been 1 year, so the IgE concentration in serum is determined the first dose. If you have stopped using xolair for a year or more, you can quantify the total IgE level in the serum to decide the dose.
The dose must be adjusted for significant changes in weight (see Table 5 and Table 6).
Chronic spontaneous urticaria
recommended dose is 300 mg of subcutaneous injection every four weeks. Symptoms can be controlled in some patients at a dose of 150 mg every four weeks.
Patients with kidney failure or liver failure
There is no study on the impact of renal failure or impaired liver function on pharmacokinetics of the xolair. Because the clearance of omalizumab at the clinical dose is mainly due to the IgG's clearance, including the divestment at the endothelium (Res) system, it is difficult to be changed due to kidney failure or liver failure. While there is no specific recommendation of adjusting the dose, the xolair should be used carefully in these patients.
Elderly
The existing data about the use of xolair for patients over 65 years old is limited, however, there is no evidence that the elderly patients need to take a different dosage than the younger adult patient.
Children
Safety and efficiency for children under 12 years of age has not been determined, so it is not recommended to use xolair for patients of this age group.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose? The maximum tolerance of xolair has not been determined. Single doses of intravenously up to 4000 mg have been used for patients without evidence of toxicity that limits the dose. The highest accumulation dose used for patients is 44000 mg for 20 weeks and this dose does not lead to any unwanted effects.
If suspected of an overdose, the patient should be monitored to see if there are any abnormal signs or symptoms. Need to identify and establish appropriate medical treatment.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using the 150 mg xolair, you may experience unwanted effects (ADR).
Common, ADR> 1/100
Reaction in the injection site: pain, erythema, itching, swelling.
Uncommon, 1/1000 circuit: lower blood pressure, blushing. Skin and subcutaneous tissue: urticaria, rash, itching, light sensitivity. Rare, ADR Anaphylaxis reactions and allergens, anti -antibodies development. Skin and subcutaneous tissue: Evaluation. Instructions on how to handle ADR Notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
SHOLAIR 150 mg is contraindicated in the following cases:
Be cautious when using
xolair is not indicated for treatment in the treatment of acute asthma attacks, acute bronchospasm or acute asthma.
xolair has not been studied in patients with an increased IgE syndrome or an Aspergillus fungal disease - allergic lungs or to prevent anaphylactic reaction.
xolair has not been fully studied in the treatment of atopic dermatitis, allergic rhinitis or food allergies.
xolair has not been studied in patients with autoimmune diseases, immunomodic intermediaries or patients with liver failure or renal failure before. Caution should be used when using xolair in these patients.
Sudden stopping of corticosteroids using systemic or inhalation form after starting to be treated with xolair is not recommended. The reduction of corticosteroid dose should be performed under the direct supervision of a doctor and may need to be conducted gradually.
IgE concentration increases during treatment and remains high to a year after stopping treatment. After the beginning of treatment, the measurement of the total IgE to determine the dose is not recommended because the IgE quantitative test also quantifies the IgE complex with omalizumab.
Allergic reaction
As with any protein, local or body allergic reactions, including anaphylaxis, may occur when using omalizumab. Therefore, the drug must be injected at a medical facility where drugs for treatment of anaphylactic reaction must be available for use right after using xolair. It is necessary to notify the patient as such reactions that can occur and the patient needs to seek medical care promptly if the allergic reaction occurs.
According to after -sales experience, anaphylactic reaction and anaphylactic reaction have been reported after the first use of the xolair or the next time. Most of these reactions occur within 2 hours.
As with all single -line antibodies, it is recombinant DNA, in rare cases, patients may develop omalizumab antibodies.
Serum disease and serum -like reactions are rare allergic reactions that have been recorded in patients treated with single -line antibodies of people including omalizumab. Starting usually from 1 to 5 days after the first injections or subsequent injections, the disease also occurs after a long period of treatment. Symptoms that suggest serum include arthritis/joint pain, rash (urticaria or other forms), fever and lymph nodes. Antihistamine and corticosteroid drugs may be helpful to prevent or treat this disorder and advise patients to report any suspected symptoms.
Parasite infection
IgE may be involved in immune response to some infected diseases. In patients at high risk and prolonged helminth infection, a fatal test with placebo in allergies shows that there is a slight increase in the infection rate when using omalizumab, although the process of infection, severity and response to the treatment of helminth infections does not change. Be careful in patients with high risk of helminth infection, especially when they go to areas where helminths infected. If the patient does not respond to anti -helminth treatment, it is necessary to stop using xolair.
The ability to drive and operate machinery
xolair does not affect or negligible effect on the ability to drive and operate machinery.
Pregnancy
There is no complete and well -controlled study of the use of omalizumab in pregnant women. IgG molecules are known to be through the placenta fence. Because animal reproductive studies do not always be predicted to be met in humans, only xolair should only be used during pregnancy when really necessary.
The period of breastfeeding
While there is no study on the presence of omalizumab in breast milk but IgG is excreted into breast milk, so Omalizumab is expected to be in breast milk. The ability to absorb omalizumab or harm the breastfeeding is not known, so it is necessary to be cautious when using xolair for nursing women.
Drug interaction
Cytochrome P450 enzymes, pumping mechanisms and binding mechanisms with proteins are not related to the clearance of omalizumab, so it is very little likely to have drug -drug interactions. There is no official research on the interaction of the drug or the vaccine with the xolair. There is no pharmacological reason to think that drugs that are often prescribed in asthma treatment will interact with omalizumab.
allergies
In clinical studies, the xolair is often used in combination with inhaled corticosteroids, oral corticosteroids, the beta 2 -effects are prolonged and short inhaled effects, Leukotriene, theophylline and anti -histamine drugs. There are no signs that the safety of xolair is changed when combined with these medications used to treat this asthma. The existing data on the use of xolair combined with specific therapeutic immunity (sensitive therapy) is limited.
Chronic spontaneous urticaria (CSU)
In chronic holved clinical studies, the xolair is used with antihistamine drugs (H1, H2 resistance) and receptor antagonists of Leukotrien (LTRAS). There is no evidence that the safety related to the known features of Omalizumab is affected by the use of these preparations. In addition, the population pharmacokinetic analysis shows no influence of antihistamine H2 and LTRAS anti -hypnosis drugs on Omalizumab's pharmacokinetics.
Storage
Store at 2–80C. Do not freeze.
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