Best Pharma Consulting Company

 What is CERDELGA? how to use?

CERDELGA is a prescription drug used for the long-term treatment of adult Gaucher disease type 1 (GD1).

Some people with Gaucher disease type 1 do not use CERDELGA. Your doctor will check to make sure that CERDELGA is right for you.

It is not known whether CERDELGA is safe and effective in children.

What are the possible side effects of CERDELGA?

See "What is the most important information I should know about CERDELGA?"

CERDELGA used with certain other drugs may cause changes in the electrical activity of the heart (ECG changes) and irregular heartbeats (arrhythmia). Tell the doctor if you have new symptoms, such as heart pits, fainting, or dizziness.

The most common side effects of CERDELGA include: fatigue, headache, nausea, diarrhea and pain in the arms, legs, back or stomach (abdomen).

Tell your doctor if you have any side effects that bother you or that will not go away. These are not all possible side effects of CERDELGA.

pharma consulting company

Call your doctor and ask for medical advice about side effects.

How should I store CERDELGA?

Store CERDELGA at room temperature between 68°F and 77°F (20°C and 25°C).

Please keep CERDELGA and all medicines out of the reach of children.

General information about the safe and effective use of CERDELGA.

Sometimes medications are prescribed for purposes other than those listed in the medication guide. Do not use CERDELGA under conditions that are not specified. Even if others have the same symptoms, do not give CERDELGA to others. May hurt them.

If you want more information, please consult your doctor. You can ask your doctor or pharmacist for information about CERDELGA, which is written for health professionals.

description

CERDELGA (eliglustat) capsules contain eliglustat tartrate, which is a small molecule inhibitor of glucosylceramide synthase, similar to the ceramide substrate of the enzyme, and its chemical name is N-((1R, 2R)-1-(2) ,3-dihydrobenzo [b]] [1,4]Dioxin-6-yl)-1-hydroxy-3-(pyrrolidin-1-yl)prop-2-yl)octamide (2R, 3R) -2,3-Dihydroxysuccinate. Its molecular weight is 479.59, the empirical formula is C23H36N2O4 + 1/2 (C4H6O6), and it has the following chemical structure:

pharma consulting company

CERDELGA® (eliglustat) structural formula-illustration

Each CERDELGA capsule taken orally contains 84 mg of egglestat (equivalent to 100 mg of egglestat tartrate). The inactive ingredients are Candulin Silver Fine Powder, FD&C Blue 2, Gelatin, Glyceryl Behenate, Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose and Yellow Iron Oxide.

Indications and dosage

Indications

CERDELGA is suitable for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) with FDA-approved tests [CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs) or poor metabolizers (PMs) [see Dosage and Administration].

Use restrictions

Patients with CYP2D6 ultra-rapid metabolizers (URM) may not achieve sufficient CERDELGA concentrations to achieve therapeutic effects [see clinical studies].

For patients who cannot determine the CYP2D6 genotype (uncertain metabolites), it is not recommended to use a specific dose [see clinical studies].

Dosage and administration

Patient selection

Patients with Gaucher disease type 1 were selected according to their CYP2D6 metabolizer status. It is recommended to use the FDA-approved test to determine the genotype of CYP2D6 to determine the genotype of the patient [see indications and usage].

Recommended adult dose

The recommended dose of CERDELGA for adults is based on the patient's CYP2D6 metabolic status.

It is very challenging to find a good pharma consulting company which is rapidly growing with remarkable note, but there are some companies that provides numerous amount of pharmaceutical consulting services


Comments

Post a Comment

Popular posts from this blog

Best Pharma Consulting Company

Image
 Drug Name Atriance 5 mg/ml infusion solution 2. Qualitative and quantitative composition Each milliliter of solution contains 5 mg of Nelarabine. Each vial contains 250 mg of Nelarabine. Excipients with known effects Each milliliter of solution contains 1.770 mg (77 micromoles) of sodium. For a complete list of excipients, see section 6.1. 3. Drug form Infusion solution. Clear colorless solution. 4. Clinical details 4.1 Treatment indications Nelarabine is suitable for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) who have not responded or relapsed after treatment with at least two chemotherapy regimens. Because the number of patients in these conditions is small, the information supporting these indications is based on limited data. 4.2 Modes and methods of administration Nelarabine can only be administered under the guidance of a doctor who has experience in the use of cytotoxic agents. Ontology The complete b...
Read more

Best Pharma Consulting Company

Image
  Indications Instruct VENCLEXTA: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Combine with azacitidine, decitabine or low-dose cytarabine for the treatment of newly diagnosed adult acute myeloid leukemia (AML): 75 years or older, or Patients with comorbidities cannot use intensive induction chemotherapy. Important safety information Contraindications In patients with CLL/SLL, simultaneous use of VENCLEXTA with strong CYP3A inhibitors is contraindicated because it may increase the risk of tumor lysis syndrome (TLS). Tumor lysis syndrome Patients treated with VENCLEXTA developed tumor lysis syndromes, including fatal events and renal failure requiring dialysis. VENCLEXTA can cause rapid tumor reduction, so in all CLL/SLL patients, there is a risk of TLS during the start and the start phase, and during the restart period after the dose is interrupted. Changes in blood chemistry consistent with TLS need to be dealt wi...
Read more

Best Pharma Consulting Company

Image
  About Veenat 400 mg tablets 10 Veenat 400 mg tablets belong to a class of drugs called "anti-cancer drugs" and are mainly used to treat various types of cancer. It is used to treat blood cancers (chronic myeloid leukemia and acute lymphocytic leukemia) and gastrointestinal stromal tumors. Cancer is a genetic change in which our cells divide uncontrollably and spread into surrounding tissues. There are more than 100 kinds of cancer, including blood cancer, lung cancer, breast cancer and so on. 10 Veenat 400 mg tablets contain imatinib, which is mainly used to treat cancer. It works by inhibiting the enzymes responsible for the proliferation of cancer cells and induces cell death (apoptosis). As a result, the growth and spread of cancer cells stopped or slowed down. Take 10 Veenat 400 mg tablets as prescribed by your doctor. It is recommended that you take 10 Veenat 400 mg tablets according to your doctor's condition, as long as your doctor has prescribed it for you. In s...
Read more