Tolosa IV Infusion 80 mg/4 ml
Tolosa IV Infusion 80 mg/4 ml Uses, Dosage, Side Effects, Food Interaction and all others data.
Tolosa IV Infusion 80 mg/4 ml is a recombinant humanized anti-human interleukin 6 (IL 6) receptor monoclonal antibody of the immunoglobulin (Ig) IgG1 subclass. Tolosa IV Infusion 80 mg/4 ml binds specifically to both soluble and membrane-bound IL 6 receptors (sIL 6R and mIL 6R), and has been shown to inhibit sIL 6R and mIL 6R-mediated signaling. Interleukin-6 is a multi-functional cytokine, produced by a variety of cell types involved in local paracrine function as well as regulation of systemic physiological and pathological processes eg, induction of immunoglobulin secretion, T-cell activation, induction of hepatic acute phase proteins and stimulation of haematopoiesis. Interleukin-6 has been implicated in the pathogenesis of diseases including inflammatory diseases, osteoporosis and neoplasia. The possibility exists for tocilizumab to affect host defences against infections and malignancies. The role of IL-6 receptor inhibition in the development of malignancies is not known.
Tolosa IV Infusion 80 mg/4 ml is an IL-6 inhibiting monoclonal antibody used to treat autoimmune and inflammatory conditions. Tolosa IV Infusion 80 mg/4 ml has a long duration of action as it is generally given every 4 weeks and has a wide therapeutic index. Patients should be counselled regarding the risk of infections, GI perforation, and hepatotoxicity.
| Trade Name | Tolosa IV Infusion 80 mg/4 ml |
| Availability | Prescription only |
| Generic | Tocilizumab |
| Tocilizumab Other Names | Atlizumab, Tocilizumab |
| Related Drugs | Actemra, Kineret, Ilaris, Humira, prednisone, Paxlovid, methotrexate, hydroxychloroquine, molnupiravir, Enbrel |
| Weight | 80 mg/4 ml |
| Type | IV Infusion |
| Formula | C6428H9976N1720O2018S42 |
| Weight | 148000.0 Da |
| Protein binding | Data regarding the serum protein binding of tocilizumab is not readily available. |
| Groups | Approved |
| Therapeutic Class | Drugs used for Rheumatoid Arthritis |
| Manufacturer | Incepta Pharmaceuticals Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
Rheumatoid Arthritis (RA): Tolosa IV Infusion 80 mg/4 ml is used for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Giant Cell Arteritis (GCA): Tolosa IV Infusion 80 mg/4 ml is used for the treatment of giant cell arteritis (GCA) in adult patients.
Polyarticular Juvenile Idiopathic Arthritis (PJIA): Tolosa IV Infusion 80 mg/4 ml is used for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Systemic Juvenile Idiopathic Arthritis (SJIA): Tolosa IV Infusion 80 mg/4 ml is used for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
Cytokine Release Syndrome (CRS): Tolosa IV Infusion 80 mg/4 ml is used for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.
Tolosa IV Infusion 80 mg/4 ml is also used to associated treatment for these conditions: Cytokine Release Syndrome caused by CAR-T Cell Therapy, Giant Cell Arteritis (GCA), Moderate to Severe Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis (SJIA)
How Tolosa IV Infusion 80 mg/4 ml works
Interleukin 6 (IL-6) is a pro-inflammatory cytokine produced by cells including T-cells, B-cells, lymphocytes, monocytes, fibroblasts. IL-6 rapidly induces C-reactive protein, serum amyloid A, fibrinogen, haptoglobin, and α-1-antichymotrypsin while inhibiting production of fibronectin, albumin, and transferrin. IL-6 also induces antibody production, induces cytotoxic T-cell differentiation, and inhibits regulatory T-cell differentiation. Tolosa IV Infusion 80 mg/4 ml binds soluble and membrane bound IL-6 receptors, preventing IL-6 mediated inflammation.
Dosage
Tolosa IV Infusion 80 mg/4 ml dosage
General (IV or SC Injection): Substitution by any other biological medicinal product requires the consent of the prescribing physician.
For adult patients with RA, tocilizumab may be administered as an IV infusion or a SC injection. For patients with pJIA and sJIA, tocilizumab is administered as an IV infusion.
Tolosa IV Infusion 80 mg/4 ml IV formulation should be diluted by a healthcare professional with sterile 0.9% w/v sodium chloride solution using aseptic technique (see Caution for Usage).
Tolosa IV Infusion 80 mg/4 ml is recommended for IV infusion over 1 hr.
Tolosa IV Infusion 80 mg/4 ml SC formulation is administered with a single-use PFS+NSD or pre-filled pen. The 1st injection should be performed under the supervision of a qualified healthcare professional. The recommended injection sites (abdomen, thigh and upper arm) should be rotated and injections should never be given into moles, scars or areas where the skin is tender, bruised, red, hard or not intact.
SC Injection: Adults: Rheumatoid Arthritis (RA): Recommended Dose: 162 mg given once every week as a SC injection. Tolosa IV Infusion 80 mg/4 ml can be used alone or in combination with MTX and/or other DMARDs.
Patients transitioning from tocilizumab IV therapy to SC administration should administer the 1st SC dose at the time of the next scheduled IV dose under the supervision of a qualified healthcare professional.
Tolosa IV Infusion 80 mg/4 ml SC formulation is not intended for IV administration. Assess suitability of patient for SC home use and instruct patients to inform a healthcare professional if they experience symptoms of allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions
Side Effects
Rheumatoid Arthritis: Patients Treated with Subcutaneous Tolosa IV Infusion 80 mg/4 ml: The safety of SC tocilizumab in RA was study in SC-I. The study compared the efficacy and safety of tocilizumab 162 mg administered every week SC versus 8 mg/kg IV in 1,262 subjects with adult RA. All patients in the study received background non-biologic DMARD(s). The safety and immunogenicity observed for tocilizumab administered SC was consistent with the known safety profile of tocilizumab IV and no new or unexpected adverse drug reactions were observed (see Table 7). A higher frequency of injection site reactions was observed in the SC arms compared with placebo SC injections in the IV arms
Toxicity
Data regarding overdoses of tocilizumab are not readily available. Patients experiencing an overdose may develop neutropenia. In case of overdose, monitor patients for signs of adverse reactions and provide symptomatic and supportive treatment.
Precaution
Serious infections leading to hospitalization or death (ie, tuberculosis; bacterial, invasive fungal, viral, or other opportunistic infections) have occurred with use Stop therapy if serious infection occurs; can restart if infection is controlled Test for latent tuberculosis before initiating; if positive, initiate tuberculosis therapy before starting tocilizumab. Continue to monitor all patients for active tuberculosis during therapy
Interaction
Interactions with Other Medicinal Products and Other Forms of Interaction: Population pharmacokinetic analyses did not detect any effect of MTX, nonsteroidal anti-inflammatory drugs or corticosteroids on tocilizumab clearance.
Concomitant administration of a single dose of 10 mg/kg tocilizumab with 10-25 mg MTX once weekly had no clinically significant effect on MTX exposure.
Tolosa IV Infusion 80 mg/4 ml has not been studied in combination with other biological DMARDs.
The expression of hepatic CYP450 enzymes is suppressed by cytokines, eg, IL-6, that stimulate chronic inflammation. Thus, CYP450 expression may be reversed when potent cytokine inhibitory therapy, eg, tocilizumab is introduced.
In vitro studies with cultured human hepatocytes demonstrated that IL-6 caused a reduction in CYP1A2, CYP2C9, CYP2C19 and CYP3A4 enzyme expression. Tolosa IV Infusion 80 mg/4 ml normalizes expression of these enzymes. The effect of tocilizumab on CYP enzymes (except CYP2C19 and CYP2D6) is clinically relevant for CYP450 substrates with a narrow therapeutic index and/or where the dose is individually adjusted.
In a study in RA patients, levels of simvastatin (CYP3A4) were decreased by 57% one week following a single dose of tocilizumab, to the level similar or slightly higher than those observed in healthy subjects.
When starting or stopping therapy with tocilizumab, patients taking medicinal products, which are individually dose-adjusted and are metabolised via CYP450 3A4, 1A2, or 2C9 (eg, atorvastatin, calcium channel blockers, theophylline, warfarin, phenytoin, ciclosporin or benzodiazepines) should be monitored as doses of these products may need to be adjusted to maintain their therapeutic effect. Given its long elimination half-life (t½), the effect of tocilizumab on CYP450 enzyme activity may persist for several weeks after stopping therapy.
Food Interaction
No interactions found.Tolosa IV Infusion 80 mg/4 ml Drug Interaction
Moderate: apixaban, atorvastatinUnknown: aspirin, erenumab, aspirin, amoxicillin / clavulanate, celecoxib, ubiquinone, duloxetine, ethanol, omega-3 polyunsaturated fatty acids, heparin, esomeprazole, acetaminophen, budesonide / formoterol, tramadol, sildenafil, ascorbic acid, cholecalciferol, menaquinone
Tolosa IV Infusion 80 mg/4 ml Disease Interaction
Major: immunizationModerate: infections, tuberculosis, demyelinating disorders, gastrointestinal perforation, liver dysfunction, renal impairment
Volume of Distribution
In rheumatoid arthritis patients, the central volume of distribution is 3.5L, the peripheral volume of distribution is 2.9L, and the volume of distribution at steady state is 6.4L. In giant cell arteritis patients, the central volume of distribution is 4.09L, the peripheral volume of distribution if 3.37L, and the volume of distribution at steady state is 7.46L. In pediatric patients with polyarticular juvenile arthritis, the central volume of distribution is 1.98L, the peripheral volume of distribution is 2.1L, and the volume of distribution at steady state is 4.08L. In pediatric patients with systemic juvenile idiopathic arthritis, the central volume of distribution is 1.87L, the peripheral volume of distribution is 2.14L, and the volume of distribution at steady state is 4.01L.
Elimination Route
A 162mg subcutaneous dose given weekly has a Cmax of 51.3±23.2µg/mL and an AUC of 8254±3833µg*h/mL. A 162mg subcutaneous dose given every 2 weeks has a Cmax of 13±8.3µg/mL and an AUC of 3460±2530µg*h/mL. A 162mg subcutaneous dose given every 4 weeks has a Cmax of 154±42µg/mL and an AUC of 39216±14304µg*h/mL.
Half Life
The half life of tocilizumab is concentration dependent. The terminal half life in rheumatoid arthritis patients is 21.5 days. The absorption half life in rheumatoid arthritis and giant cell arteritis patients was 4 days, and in polyarticular juvenile idiopathic arthritis patients and systemic juvenile idiopathic arthritis patients was 2 days.
Clearance
The linear clearance in rheumatoid arthritis patients is 12.5mL/h, in giant cell arteritis patients is 6.7mL/h, in polyarticular juvenile idiopathic arthritis patients is 5.8mL/h, and in systemic juvenile idiopathic arthritis is 5.7mL/h. Clearance is dose dependent and changes from non linear at low doses to linear at higher doses.
Elimination Route
Data regarding the exact route of elimination of monoclonal antibodies is not readily available.
Pregnancy & Breastfeeding use
Pregnancy Category- C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Lactation: Unknown whether distributed in breast milk, do not breast feed
Contraindication
Hypersensitivity to tocilizumab or to any of the excipients.
Special Warning
Children: The safety and efficacy of tocilizumab in children with conditions other than pJIA or sJIA have not been established.
Children Elderly: No dose adjustment is required in elderly patients ≥65 years.
Renal Impairment: No dose adjustment is required in patients with mild renal impairment (see Pharmacology: Pharmacokinetics under Actions). Tolosa IV Infusion 80 mg/4 ml has not been studied in patients with moderate to severe renal impairment.
Hepatic Impairment: The safety and efficacy of tocilizumab has not been studied in patients with hepatic impairment (see Precautions).
Acute Overdose
There are limited data available on overdosage with tocilizumab. One (1) case of accidental overdose was reported in which a patient with multiple myeloma received a single dose of 40 mg/kg IV. No adverse drug reactions were observed. No serious adverse drug reactions were observed in healthy volunteers who received a single dose up to 28 mg/kg IV, although dose-limiting neutropenia was observed.
Storage Condition
Store at a temperature of 2-8°C. Do not freeze. Protect from light and keep dry.
Innovators Monograph
You find simplified version here Tolosa IV Infusion 80 mg/4 ml
Tolosa IV Infusion 80 mg/4 ml contains Tocilizumab see full prescribing information from innovator Tolosa IV Infusion 80 mg/4 ml Monograph, Tolosa IV Infusion 80 mg/4 ml MSDS, Tolosa IV Infusion 80 mg/4 ml FDA label
FAQ
What is Tolosa IV Infusion 80 mg/4 ml used for?
Tolosa IV Infusion 80 mg/4 ml is used s to treat moderate to severe rheumatoid arthritis in adults. It is also used to treat rheumatoid arthritis in children. It helps to reduce pain and swelling due to rheumatoid arthritis. Tolosa IV Infusion 80 mg/4 ml is also used to treat giant cell arteritis. It helps to reduce swelling in your blood vessels so blood can flow more easily.It is used to treatment is effective to reduce the mortality of severe COVID-19.
What are the common side effects of Tolosa IV Infusion 80 mg/4 ml?
The most common side effects are:
- a cough or sore throat, blocked or runny nose
- headaches or dizziness
- mouth ulcers
- high blood pressure
- hypercholesterolaemia (increased cholesterol in the blood)
- allergic reactions - this can include aching muscles, feeling out of breath, having a tight chest, wheezing, and a high temperature
- weight gain or swollen ankles
- skin rashes, infections or itching
- stomach irritation or abdominal pain.
Does Tolosa IV Infusion 80 mg/4 ml effects on cholesterol liver function?
Tolosa IV Infusion 80 mg/4 ml can increase your cholesterol levels and also can affect liver function tests. As a result, you will need a blood test every four weeks while taking Tolosa IV Infusion 80 mg/4 ml.
Does Tolosa IV Infusion 80 mg/4 ml make me dizzy?
You may feel dizzy while taking Tolosa IV Infusion 80 mg/4 ml.This could affect your ability to drive and perform other tasks.
Can I drink alcohol with Tolosa IV Infusion 80 mg/4 ml?
There’s no particular reason to avoid alcohol while taking Tolosa IV Infusion 80 mg/4 ml. However, the government guidelines say that both men and women should drink no more than 14 units of alcohol a week, and that you should spread these through the week rather than having them all in one go.
Is Tolosa IV Infusion 80 mg/4 ml safe during pregnancy?
Tolosa IV Infusion 80 mg/4 ml should be avoided during pregnancy, unless essential, as it’s not yet known how the drug can affect an unborn baby.
If you’ve taken Tolosa IV Infusion 80 mg/4 ml in the early stages of a pregnancy, it’s unlikely to be harmful.
Is Tolosa IV Infusion 80 mg/4 ml safe during breastfeeding?
You should be OK to breastfeed while taking Tolosa IV Infusion 80 mg/4 ml, but the research is limited so it would be a good idea to talk to your doctor about this.
There is currently no evidence that men must stop Tolosa IV Infusion 80 mg/4 ml if they are trying to father a baby.
How long can I take Tolosa IV Infusion 80 mg/4 ml?
Tolosa IV Infusion 80 mg/4 ml will work within three to six months, if it is going to work at all. Some patients may feel better as early as two weeks after starting treatment.
Can I drive after taking Tolosa IV Infusion 80 mg/4 ml?
You may feel dizzy while taking Tolosa IV Infusion 80 mg/4 ml. This could affect your ability to drive and perform other tasks.
How does Tolosa IV Infusion 80 mg/4 ml work?
Tolosa IV Infusion 80 mg/4 ml works to reduce this rush of immune chemicals to the affected area, and means there is less inflammation and damage to the lungs.
Will I gain or lose weight of Tolosa IV Infusion 80 mg/4 ml?
The patients' body weights increased after Tolosa IV Infusion 80 mg/4 ml therapy, even among the non-responders, but no weight gains were observed among the patients who were treated with methotrexate. Therefore, weight gain appeared to be a drug-specific effect.
Does Tolosa IV Infusion 80 mg/4 ml cause hair loss?
Tolosa IV Infusion 80 mg/4 ml isn't known to cause hair loss
How is Tolosa IV Infusion 80 mg/4 ml eliminated?
Tolosa IV Infusion 80 mg/4 ml undergoes biphasic elimination from the circulation.
Does Tolosa IV Infusion 80 mg/4 ml lower immune system?
Tolosa IV Infusion 80 mg/4 ml affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.
