Uses of IDHIFA

 use

The IDHIFA drug is used to treat certain types of blood cell carcinoma (acute myeloid leukemia-AML). Enasidenib works by helping your bone marrow grow normal blood cells, so you need less blood transfusions.
How to use Idhifa

Please read the Medication Guide provided by your pharmacist before you start taking Enatinib and every time you supplement it. If you have any questions, please consult your doctor or pharmacist.

Follow your doctor's instructions to take this medication by mouth, with or without food, usually once a day. Swallow the entire tablet. Do not crush or split the tablets.

Unless your doctor instructs otherwise, take this medicine with a full glass of water (8oz/240ml).

The dosage depends on your medical condition and response to treatment.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time every day.

Do not increase the dose or use this medication more than prescribed. Your condition will not get better soon, and the risk of serious side effects will increase.

If you vomit after taking this medicine, take another dose as soon as possible on the same day. Then take the next dose at the normal time the next day. Do not double the dose to catch up.

Side effects of Elprase

 Common side effects of Elaprase include: abscess, chest wall pain, dyspepsia, infusion related reaction, pruritic rash, pruritus, urticaria, and visual disturbance. See below for a comprehensive list of adverse effects.

 

Side effects requiring immediate medical attention

Along with its needed effects, idursulfase (the active ingredient contained in Elaprase) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking idursulfase:

More common

• Bone or muscle pain
• chest pain
• chills
• cough
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• fever
• headache
• hives or welts
• itching
• rash
• redness of the face, neck, arms, and occasionally, upper chest
• redness of the skin
• sneezing
• sore throat
• tightness in the chest
• unusual tiredness or weakness

Less common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating

Incidence not known

• Difficulty with swallowing
• dilated neck veins
• extreme fatigue
• heart stops
• irregular breathing
• no breathing
• no pulse or blood pressure
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unconscious
• weight gain

Side effects not requiring immediate medical attention

Some side effects of idursulfase may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in hearing
• diarrhea
• ear drainage
• earache or pain in the ear

Less common

• Nausea
• vomiting

Overview of Elaprase

Elaprase (idursulfase) is an IV infusion used to treat some of the symptoms of a genetic condition called Hunter's syndrome, also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis). Idursulfase contains a natural enzyme that some people lack because of a genetic disorder. Elaprase helps replace this missing enzyme.

Hunter syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision loss, and changes in mental or physical abilities.

Elaprase may improve walking ability in people with this condition. However, this medication is not a cure for Hunter syndrome.

Important information

Elaprase may improve walking ability in people with Hunter syndrome. However, Elaprase is not a cure for this condition.

Some side effects may occur during the infusion, or up to 24 hours afterward. Get emergency medical help if you have any signs of an allergic reaction: feeling like you might pass out; hives; trouble breathing; seizure (convulsions); swelling of your face, lips, tongue, or throat.

You may be more likely to have a reaction to Elaprase if you have a breathing disorder. named patient program,Tell your doctor if you have asthma or other lung disease.

CARBAGLU DOSAGE AND ADMINISTRATION

Recommended Dosage

CARBAGLU should be initiated as soon as the diagnosis of NAGS deficiency is suspected, which may be as soon as at birth, and managed by a physician and medical team experienced in metabolic disorders.

Initial Dosage

The recommended initial daily dosage of CARBAGLU in pediatric and adult patients for acute hyperammonemia is 100 mg/kg to 250 mg/kg divided into 2 to 4 doses and rounded to the nearest 100 mg (i.e., half of a CARBAGLU tablet). Concomitant administration of other ammonia lowering therapies is recommended.

Maintenance Dosage

The recommended daily maintenance dosage of CARBAGLU in pediatric and adult patients is 10 mg/kg to 100 mg/kg divided into 2 to 4 doses and rounded to the nearest 100 mg (i.e., half of a CARBAGLU tablet).

Therapeutic Monitoring

Closely monitor plasma ammonia levels. Titrate the CARBAGLU dosage to maintain the plasma ammonia level within the normal range for the patient's age, taking into consideration their clinical condition (e.g., nutritional requirements, protein intake, growth parameters, etc.).

Preparation And Administration

    Disperse CARBAGLU tablets in water. Do not swallow whole or crushed.
    Mix each 200 mg tablet in a minimum of 2.5 mL of water to yield a concentration of 80 mg/mL.
    CARBAGLU tablets do not dissolve completely in water and undissolved particles of the tablet may remain in the mixing container.
    Take CARBAGLU immediately before meals or feedings.
    The CARBAGLU suspension has a slightly acidic taste.
    For all preparations, use in foods or liquids, other than water, has not been studied clinically and is not recommended.

Preparation For Oral Administration In Pediatric And Adult Patients

    Add about 2.5 mL of water into a small cup for each CARBAGLU tablet or each ½ CARBAGLU tablet needed for the prescribed dose.
    Add the CARBAGLU tablets to the water in the cup.
    Carefully stir the tablet and water mixture.
    Swallow the mixture immediately. Pieces of the tablet may remain in the cup.
    Rinse the cup with additional water and swallow the mixture immediately. Repeat as needed until no pieces of the tablet are left in the cup.

Preparation For Nasogastric Tube Administration In Pediatric And Adult Patients

For patients who have a nasogastric tube in place, CARBAGLU should be administered as follows:

    Add about 2.5 mL of water into a small cup for each CARBAGLU tablet or each ½ CARBAGLU tablet needed for the prescribed dose.
    Add the CARBAGLU tablets to the water in the cup.
    Carefully stir the tablet and water mixture.
    Draw up the mixture into a catheter-tip syringe.
    Administer the mixture immediately through the nasogastric (NG) tube. Pieces of the tablet may remain in the catheter-tip syringe or NG tube.
    Flush immediately with 1 to 2 mL of additional water to clear the NG tube.
    Flush the NG tube again, as needed, until no pieces of the tablet are left in the syringe or NG tube.

Preparation For Oral Administration Using An Oral Syringe In Pediatric Patients

For administration via oral syringe, CARBAGLU should be administered as follows:

    Add about 2.5 mL of water into a small cup for each CARBAGLU tablet or each ½ CARBAGLU tablet needed for the prescribed dose.
    Add the CARBAGLU tablets to the water in the cup.
    Carefully stir the tablet and water mixture.
    Draw up the mixture in an oral syringe and administer immediately. Pieces of the tablet may remain in the oral syringe.
    Refill the oral syringe with a minimum volume of water (1 to 2 mL) and administer immediately.
    Flush the oral syringe again, as needed, until no pieces of the tablet are left in the syringe.

CARBAGLU DOSAGE AND INDICATION

 CARBAGLU tablets for oral suspension, contain 200 mg of carglumic acid. Carglumic acid, the active substance, is a Carbamoyl Phosphate Synthetase 1 (CPS 1) activator and is soluble in boiling water, slightly soluble in cold water, and practically insoluble in organic solvents.

Chemically carglumic acid is N-carbamoyl-L-glutamic acid or (2S)-2-(carbamoylamino) pentanedioic acid, with a molecular weight of 190.16.

Molecular Formula: C6H10N2O5

The inactive ingredients of CARBAGLU are croscarmellose sodium, hypromellose, microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulfate, sodium stearyl fumarate.

INDICATIONS

Acute Hyperammonemia In Patients With NAGS Deficiency

CARBAGLU is indicated as an adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia due to the deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). During acute hyperammonemic episodes, concomitant administration of CARBAGLU with other ammonia lowering therapies, such as alternate pathway medications, hemodialysis, and dietary protein restriction, is recommended.

Chronic Hyperammonemia In Patients With NAGS Deficiency

CARBAGLU is indicated as maintenance therapy in pediatric and adult patients for the treatment of chronic hyperammonemia due to deficiency of the hepatic enzyme N-acetylglutamate synthase (NAGS). Named patient program, During maintenance therapy, the concomitant use of other ammonia lowering therapies and protein restriction may be needed based on plasma ammonia levels.

Indication and Dosage of Cerdelga

 INDICATIONS

CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test [see DOSAGE AND ADMINISTRATION].
Limitations Of Use

   named  Patient program who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect [see Clinical Studies].
    A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers) [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients with Gaucher disease type 1 based on their CYP2D6 metabolizer status. It is recommended patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype.

Important Administration Instructions

•     Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules.
•     CERDELGA can be taken with or without food.
•     Avoid the consumption of grapefruit or grapefruit juice (strong CYP3A inhibitors) with CERDELGA [see DRUG INTERACTIONS].
•     If a dose of CERDELGA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
•     For patients currently treated with imiglucerase, velaglucerase alfa, or taliglucerase alfa, CERDELGA may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT).

What is CERDELGA and how is it used?

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

CERDELGA is not used in certain people with Gaucher disease type 1. Your doctor will perform a test to make sure that CERDELGA is right for you.

It is not known if 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 medicines, may cause changes in the electrical activity of your heart (ECG changes) and irregular heart beat (arrhythmias). Tell your doctor if you have new symptoms such as palpitations, fainting, or dizziness.

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

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CERDELGA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CERDELGA?

    Store CERDELGA at room temperature between 68°F to 77 °F (20°C to 25 °C).
    Keep CERDELGA and all medicines out of reach of children.

General information about the safe and effective use of CERDELGA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CERDELGA for a condition for which it was not prescribed. Do not give CERDELGA to other people, even if they have the same symptoms you have. It may harm them.

If you would like more information, talk with your doctor. named patient india You can ask your doctor or pharmacist for information about CERDELGA that is written for health professionals.