Best Pharma Consulting Company

 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 blood count, including platelets, must be monitored regularly (see sections 4.4 and 4.8).

Adults and teenagers (over 16 years old)

For adults and adolescents 16 years and older, the recommended dose of Nelarabine is 1,500 mg/m2, administered intravenously within two hours on Day 1, Day 3, and Day 5, every 21 days repeat.

Children and adolescents (under 21 years old)

For children and adolescents (under 21 years of age), the recommended dose of Nelarabine is 650 mg/m2, daily for 1 consecutive day for 5 consecutive days, intravenously administered daily, repeated every 21 days.

In clinical studies, both 650 mg/m2 and 1,500 mg/m2 doses are used for patients between 16 and 21 years of age. The efficacy and safety of the two programs are similar. When treating patients of this age, the prescriber should consider which treatment plan is appropriate.

Limited clinical pharmacology data are available for patients under 4 years of age (see section 5.2).

Dosage modification

Nelarabine must be discontinued at the first sign of a neurological event of grade 2 or higher at the National Cancer Institute Common Terminology Standard Adverse Event (NCI CTCAE). Delaying subsequent dosing is an option for other toxicities, including hematological toxicity.

Special population

elderly

The number of underage patients over 65 who are receiving nelarabine is insufficient to determine whether their response is different from that of younger patients (see sections 4.4 and 5.2).

Renal insufficiency

Nelarabine has not been studied in patients with renal insufficiency. Nelarabine and 9-β-D-arabinofuranosylguanine (ara-G) are partially excreted by the kidneys (see section 5.2). For patients with renal clearance and creatinine Clcr of less than 50 ml/min, there are insufficient data to support dose adjustment recommendations. When using nelarabine for treatment, the toxicity of patients with renal insufficiency must be closely monitored.

Liver insufficiency

Nelarabine has not been studied in patients with liver insufficiency. These patients should be treated with caution.

Method of administration

Nelarabine is for intravenous use only and should not be diluted before administration. The appropriate dose of Nelarabine must be transferred to a polyvinyl chloride (PVC) or vinyl ethyl acetate (EVA) infusion bag or glass container. Adult patients will be given an intravenous infusion for 2 hours and pediatric patients will be infused for 1 hour.

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