Zavesca Indications & Dosage

 Zavesca is a glucosylceramide synthase inhibitor and is indicated as a monotherapy for adult patients with mild to moderate type 1 Gaucher disease. For these patients, enzyme replacement therapy is not a treatment option (for example, due to allergies, Hypersensitivity or poor venous access).

Dosage and administration

Management Instructions

Treatment should be guided by a doctor who has a good understanding of Gaucher's disease.

The recommended dose for adults with type 1 Gaucher disease is one 100 mg capsule orally three times a day. If a dose is missed, the next Zavesca capsule should be taken at the next scheduled time.

In some patients, due to adverse reactions such as tremor or diarrhea, it may be necessary to reduce the dose to 100 mg capsules once or twice a day.

Patients with renal insufficiency

For patients with mild renal insufficiency (adjusted creatinine clearance 50-70 mL/min / 1.73m²), the administration of Zavesca should be started with a dose of 100 mg twice a day. For patients with moderate renal insufficiency (adjusted creatinine clearance rate of 30-50 mL/min / 1.73m²), the administration of Zavesca should start with a daily dose of 100 mg capsules. Zavesca is not recommended for named patient basis with severe renal insufficiency (creatinine clearance <30 mL / min / 1.73m²)

ZAVESCA capsule uses

 

 Zavesca (miglustat capsules, 100 mg) is an inhibitor of glucosylceramide synthase, which is the first glucosyltransferase responsible for the synthesis of most glycosphingolipids.

Zavesca is an N-alkylated imino sugar, which is a synthetic analog of D-glucose.

The chemical name of miglustat is 1,5-(butylimino)-1,5-dideoxy-D-glucitol, the chemical formula is C10H21NO4, and the molecular weight is 219.28.



Miglustat is a white to off-white crystalline solid with a bitter taste. It is highly soluble in water (>1000 mg/mL is free base).

Zavesca is available in hard gelatin capsules, each capsule containing 100 mg of miglustat orally. named patient program, Each Zavesca 100 mg capsule also contains sodium starch glycolate, povidone (K30) and magnesium stearate. The ingredients in the capsule shell include gelatin and titanium dioxide, and the shell is printed with edible ink composed of black iron oxide and shellac.

ORENCIA SIDE EFFECTS

 Because clinical trials are conducted under widely varying and controlled conditions, it is impossible to directly compare the adverse reaction rate observed in the drug clinical trial with the incidence in the clinical trial of another drug, and may not be predictable in clinical practice The adverse reaction rate observed in the wider patient population.

Like all therapeutic proteins, it has the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. In addition, the incidence of positive antibodies (including neutralizing antibodies) observed in the assay may be affected by several factors, including the assay method, sample processing, sample collection time, concomitant medications and underlying diseases. named patient supply For these reasons, comparing the incidence of abatacept antibodies in the studies described below with the incidence of antibodies in other studies or other products may be misleading.

Clinical research experience of Orencia intravenous injection in adult RA patients

The data described in this article reflect the intravenous use of Orencia in patients with active RA in a placebo-controlled study (Orencia patients in 1955, 989 placebo patients).named patient medicines The double-blind placebo-controlled period of the study was 6 months (258 ORENCIA patients, 133 placebo) or 1 year (1697 ORENCIA patients, 856 placebo). Some of these patients received biological DMARD therapy, such as TNF blockers (204 ORENCIA patients and 134 placebo patients).

Most patients in RA clinical studies receive one or more of the following ORENCIA concomitant drugs: methotrexate, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, TNF blockers, azathioprine, chloroquine, gold, hydroxy Chloroquine, leflunomide, sulfasalazine and anakinra.

The most serious adverse reactions are serious infections and malignant tumors.

The most common adverse events (occurring in ≥10% of patients treated with ORENCIA) were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

The most common adverse event (interruption or discontinuation of ORERNCIA) of clinical intervention is caused by infection. pharmaceutical consulting companies The most frequently reported infections that caused dose interruptions were upper respiratory tract infection (1.0%), bronchitis (0.7%), and herpes zoster (0.7%). The most common infections leading to discontinuation are pneumonia (0.2%), local infection (0.2%) and bronchitis (0.1%).

DOSAGE AND ADMINISTRATION ORENCIA

Adult rheumatoid arthritis

For adult patients with RA, ORENCIA can be administered by intravenous infusion or subcutaneous injection.

ORENCIA can be used as a monotherapy or with DMARDs other than TNF antagonists.
IV regimen

Orerncia lyophilized powder should be diluted and used after dilution [see adult psoriatic arthritis], and intravenous infusion of 30 minutes according to the dose based on the weight range specified in Table 1. After the first intravenous administration, intravenous infusion should be given at 2 and 1. 4 weeks after the first infusion and every 4 weeks thereafter.

Subcutaneous dosing regimen

ORENCIA 125 mg in a prefilled syringe or in the ORENCIA ClickJect™ auto-injector should be injected subcutaneously once a week [see preparation and dosing instructions for intravenous infusion], and can be started with or without an intravenous dose . named patient program For patients starting treatment with an intravenous loading dose, ORENCIA should be started with a single intravenous infusion (according to the weight category listed in Table 1), and then the first 125 mg subcutaneous injection should be given within the same day of the intravenous infusion.

Patients transitioning from Orencia intravenous therapy to subcutaneous administration should be given the first subcutaneous dose instead of the next scheduled intravenous dose.
Juvenile idiopathic arthritis

For patients with juvenile idiopathic arthritis (JIA), ORENCIA can be administered by intravenous infusion (6 years and older) or subcutaneous injection (2 years and older). No intravenous administration was given to patients under 6 years of age.

ORENCIA can be used as a monotherapy or concurrently with methotrexate.
IV regimen

ORENCIA should be administered as a 30-minute intravenous infusion based on body weight. Pediatric patients:

 People weighing less than 75 kg should be administered ORENCIA at a dose of 10 mg/kg [see Adult Psoriatic Arthritis] After the adult intravenous administration regimen (see Table 1), Orencia should be given a body weight of 75 kg or more, and the maximum dose should not exceed 1,000 mg.

After the initial administration, ORENCIA should be administered 2 and 4 weeks after the first infusion and every 4 weeks thereafter. named patient basis,The unused part of the sample bottle must be discarded immediately.
Subcutaneous dosing regimen

Orencia for subcutaneous injection should be started without an intravenous dose, and the dose based on the weight range specified in Table 2 should be used.

ORENCIA INDICATIONS

INDICATIONS

Adult rheumatoid arthritis (RA)

ORENCIA® is suitable for alleviating the symptoms and signs of adult patients with moderate to severe active rheumatoid arthritis, causing significant clinical reactions, inhibiting the progression of structural damage and improving physical function. In addition to tumor necrosis factor (TNF) antagonists, Pharmaceutical Consulting Company OERNCIA can also be used as a monotherapy or in conjunction with disease-modifying anti-rheumatic drugs (DMARD).

Juvenile idiopathic arthritis

ORENCIA is indicated for alleviating signs and symptoms of adolescent idiopathic arthritis with moderately to severely active polyarticular joints aged 2 years and older. ORENCIA can be used as a monotherapy or in combination with methotrexate (MTX).

Adult Psoriatic Arthritis (PsA)

ORENCIA is designated for the treatment of adult patients with active psoriatic arthritis (PsA).

Important usage restrictions

ORENCIA should not be used simultaneously with TNF antagonists. Named patient supply It is not recommended to use ORENCIA together with other biological rheumatoid arthritis (RA) treatments (such as anakinra).

ORENCIA (abatacept) Injection

DESCRIPTION

ORENCIA® (abatacept) is a selective T cell costimulatory modulator. ORENCIA is a soluble fusion protein consisting of the extracellular domain of human cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and a modified Fc (hinge, CH2 and CH3 domain) of human immunoglobulin G1 (IgG1). . Abatacept is produced in mammalian cell expression systems through recombinant DNA technology. The apparent molecular weight of abatacept is 92 kilodaltons.

ORENCIA injection is a lyophilized powder for intravenous infusion. ORENCIA injection is a sterile, white, preservative-free lyophilized powder that can be reconstituted and diluted before intravenous administration. After reconstituting the lyophilized powder with 10 mL of sterile water for injection (USP), the ORENCIA solution is clear, colorless to light yellow, and the pH is 7.2 to 7.8. Each single-use ORENCIA injection bottle provides 250 mg abatacept, maltose (500 mg), sodium dihydrogen phosphate (17.2 mg) and sodium chloride (14.6 mg) for administration.

ORENCIA injection is a sterile, preservative-free, transparent to slightly milky white, colorless to light yellow solution, and the pH range for subcutaneous administration is 6.8 to 7.4. named patient program ORENCIA injections are available as single-dose pre-filled syringes or single-dose ClickJect auto-injectors

EMPLICITI INDICATIONS

EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

DOSAGE AND ADMINISTRATION

Recommended Dosing When EMPLICITI Is Used In Combination With Lenalidomide And Dexamethasone

The recommended dosage of EMPLICITI is 10 mg/kg administered intravenously every week for the first two cycles (28-day cycle) and every 2 weeks thereafter in conjunction with the recommended dosing of lenalidomide and low-dose dexamethasone as described below. Continue treatment until disease progression or unacceptable toxicity.

Refer to the dexamethasone and lenalidomide prescribing information for additional information. Administer premedications before each dose of EMPLICITI [see Premedication and WARNINGS AND PRECAUTIONS].

Administer dexamethasone as follows:

On days that EMPLICITI is administered, Pharmaceutical Consulting Company give dexamethasone 28 mg orally between 3 and 24 hours before EMPLICITI plus 8 mg intravenously between 45 and 90 minutes before EMPLICITI. On days that EMPLICITI is not administered but a dose of dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), give 40 mg orally.
 

EMPLICITI ( Uses, Doses, Side effects )

Elotuzumab is a humanized recombinant monoclonal antibody directed against SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementarity determining region (CDR) of the mouse antibody MuLuc63, which is grafted onto the framework of the human IgG1 heavy chain and kappa light chain. Elotuzumab is produced in NS0 cells by recombinant DNA technology. The theoretical mass of the intact antibody of Eclozumab is 148.1 kDa.

EMPLICITI (Elocizumab) is a sterile, pyrogen-free, preservative-free lyophilized powder that is white to off-white in a single-dose vial, whole or fragmented cakes. EMPLICITI for injection is provided at the price of 300 mg per bottle and 400 mg per bottle, and needs to be formulated with sterile water for injection USP (13 mL and 17 mL, respectively) to obtain a solution with a concentration of 25 mg/mL. After reconstitution, each vial contains excess filling to allow 12 mL (300 mg) and 16 mL (400 mg) to be pumped. named patient program, The reconstituted solution is colorless to slightly yellow, transparent to slightly opalescent. Before intravenous infusion, dilute the reconstituted solution with 0.9% Sodium Chloride Injection USP or 5% Dextrose Injection USP [see Dosage and Usage].

Each EMPLICITI 300 mg single-dose vial also contains the following inactive ingredients: citric acid monohydrate (2.44 mg), polysorbate 80 (3.4 mg), sodium citrate (16.6 mg) and sucrose (510 mg).

Each EMPLICITI 400 mg single-dose vial also contains the following inactive ingredients: citric acid monohydrate (3.17 mg), polysorbate 80 (4.4 mg), sodium citrate (21.5 mg) and sucrose (660 mg).