Arranon (Page 5 of 5)

14.2 Pediatric Clinical Trial in Relapsed or Refractory T-ALL and T-LBL

The safety and efficacy of ARRANON in pediatric patients were studied in a clinical trial which included patients age 21 years and younger, who had relapsed or refractory T-ALL or T-LBL. Eighty-four (84) patients, 39 of whom had received two or more prior induction regimens, were treated with 650 mg/m2 /day of ARRANON administered intravenously over 1 hour daily for 5 consecutive days repeated every 21 days (see Table 6). Patients who experienced signs or symptoms of Grade 2 or greater neurologic toxicity on therapy were to be discontinued from further therapy with ARRANON.

Table 6. Pediatric Clinical Trial — Patient Allocation
Abbreviations: T-ALL, T-cell acute lymphoblastic leukemia; T-LBL, T-cell lymphoblastic lymphoma.
Patient Population N
Patients treated at 650 mg/m2 /day x 5 days, every 21 days 84
Patients with T-ALL or T-LBL with two or more prior induction treated at 650 mg/m2 /day x 5 days, every 21 days 39
Patients with T-ALL or T-LBL with one prior induction treated at 650 mg/m2 /day x 5 days, every 21 days 31

The 84 patients ranged in age from 2.5 to 21.7 years (overall mean: 11.9 years), 52% were 3 to 12 years of age and most were male (74%) and Caucasian (62%). The majority (77%) of patients had a diagnosis of T-ALL.

Complete response (CR) in this trial was defined as bone marrow blast counts ≤ 5%, no other evidence of disease, and full recovery of peripheral blood counts. Complete response without full hematologic recovery (CR*) was also assessed as a meaningful outcome in this trial. Duration of response is reported from date of response to date of relapse, and may include subsequent stem cell transplant. Efficacy results are presented in Table 7.

Table 7. Efficacy Results in Patients Age 21 Years and Younger at Diagnosis With ≥ 2 Prior Inductions Treated With 650 mg/m2 of ARRANON Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days
Abbreviations: CR, complete response; CI, confidence interval;CR*, complete response without hematologic recovery.a Does not include 5 patients who were transplanted or had subsequent systemic chemotherapy (duration of response in these 5 patients was 4.7 to 42.1 weeks).
N = 39
CR plus CR* % (n) [95% CI] 23% (9) [11%, 39%]
CR % (n) [95% CI] 13% (5) [4%, 27%]
CR* % (n) [95% CI] 10% (4) [3%, 24%]
Duration of CR plus CR* (range in weeks)a 3.3 to 9.3
Median overall survival (weeks) [95% CI] 13.1 [8.7, 17.4]

The mean number of days on therapy was 46 days (range: 7-129 days). Median time to CR plus CR* was 3.4 weeks (95% CI: 3.0, 3.7).

15 REFERENCES

  1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

ARRANON Injection is supplied as a clear, colorless, sterile solution in Type I, clear glass single-dose vials with a gray bromobutyl rubber stopper (not made with natural rubber latex) and an aluminum seal with a red snap-off cap. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in 50 mL Water for Injection, USP.

Single-dose Vials are available in the following carton sizes:

NDC 0078-0683-61 (package of 1).

NDC 0078-0683-06 (package of 6).

Store ARRANON (nelarabine) Injection between 20°C and 25°C (68°F and 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Hematologic Adverse Reactions

  • Advise patients that leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia, have been associated with ARRANON.
  • Advise patients that complete blood counts, including platelets, will be monitored regularly during treatment [see Warnings and Precautions (5.2), Adverse Reactions (6.1)].

Embryo-Fetal Toxicity

  • Advise pregnant females of reproductive potential and males with female partners of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ARRANON. Instruct females to inform their physician of a known or suspected pregnancy.
  • Advise male patients with partners of reproductive potential to use condoms during treatment with ARRANON and for 3 months after the last dose [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Tumor Lysis Syndrome

  • Advise patients of the risk of tumor lysis syndrome [see Warnings and Precautions (5.4), Adverse Reactions (6.1)].

Vaccinations

  • Instruct patients not to receive live vaccines during treatment with ARRANON [see Warnings and Precautions (5.5), Adverse Reactions (6.1)].

Effects on Ability to Drive and Use Machines

  • Patients receiving ARRANON may experience somnolence during and for several days after treatment. Instruct patients to not drive or engage in hazardous occupations or activities until somnolence has resolved [see Warnings and Precautions (5.6), Adverse Reactions (6.1)].

Neurologic Adverse Reactions

  • Instruct patients to contact their physician if they experience new or worsening symptoms of peripheral neuropathy [see Boxed Warning, Dosage and Administration (2.3), Warnings and Precautions (5.1), Adverse Reactions (6.1)]. These signs and symptoms include: tingling or numbness in fingers, hands, toes, or feet; difficulty with the fine motor coordination tasks such as buttoning clothing; unsteadiness while walking; weakness arising from a low chair; weakness in climbing stairs; increased tripping while walking over uneven surfaces.
  • Advise patients of the risk of seizures [see Adverse Reactions (6.1)]. If a seizure occurs, instruct patients to promptly notify the physician administering ARRANON.

Infection

  • Instruct patients to promptly notify their physician if they develop fever or signs of infection while on therapy [see Adverse Reactions (6.1, 6.2)].

Lactation

  • Advise women not to breastfeed during treatment with ARRANON [see Use in Specific Populations (8.2)].

Distributed by:
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

© Novartis

T2019-90

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: July 2019
PATIENT INFORMATIONARRANON® (AIR-ra-non) (nelarabine) Injection

Read the Patient Information that comes with ARRANON before you or your child starts treatment with ARRANON. Read the information you get each time before each treatment with ARRANON. There may be new information. This information does not take the place of talking with the doctor about your or your child’s medical condition or treatment. Talk to your or your child’s doctor, if you have any questions.

What is the most important information I should know about ARRANON?

ARRANON may cause blood related adverse reactions. Your doctor will do blood tests regularly during treatment to monitor blood counts, including platelets.

ARRANON may cause serious nervous system problems including:

  • extreme sleepiness
  • seizures
  • coma
  • numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy)
  • weakness and paralysis

Call the doctor right away if you or your child has the following symptoms:

  • seizures
  • numbness and tingling in the hands, fingers, feet, or toes
  • problems with fine motor skills such as buttoning clothes
  • unsteadiness while walking
  • increased tripping while walking
  • weakness when getting out of a chair or walking upstairs

These symptoms may not go away even when treatment with ARRANON is stopped.

What is ARRANON?

ARRANON is an anti-cancer medicine used to treat adults and children who have:

  • T-cell acute lymphoblastic leukemia (T-ALL)
  • T-cell lymphoblastic lymphoma (T-LBL)

What should you tell the doctor before you or your child starts ARRANON?

Tell the doctor about all health conditions you or your child have, including if you or your child:

  • have any nervous system problems.
  • have kidney problems.
  • are breastfeeding or plan to breastfeed. It is not known whether ARRANON passes through breast milk. You should not breastfeed during treatment with ARRANON.
  • are pregnant or plan to become pregnant. ARRANON can harm your unborn baby. You should not become pregnant while you are taking ARRANON. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.
  • are male (including if you have had a vasectomy) with a sexual partner who is pregnant, think that they may be pregnant, or who could become pregnant. You should use condoms during sexual intercourse during treatment with ARRANON and for 3 months after last dose.

Tell the doctor about all the medicines you or your child take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

How is ARRANON given?

ARRANON is an intravenous medicine. This means it is given through a tube in your vein.

What should you or your child avoid during treatment with ARRANON?

  • You or your child should not drive or operate dangerous machines. ARRANON may cause sleepiness during and for several days after treatment.
  • You or your child should not receive vaccines made with live germs during treatment with ARRANON.

What are the possible side effects of ARRANON?

ARRANON may cause serious nervous system problems. See “What is the most important information I should know about ARRANON?

ARRANON may also cause:

  • decreased blood counts such as low red blood cells, low white blood cells, and low platelets. Blood tests should be done regularly to check blood counts. Call the doctor right away if you or your child:• is more tired than usual, pale, or has trouble breathing• has a fever or other signs of an infection• bruises easy or has any unusual bleeding
  • stomach area problems such as nausea, vomiting, diarrhea, and constipation
  • headache
  • sleepiness
  • blurry eyesight

Call your doctor right away if you experience unexplained muscle pain, tenderness, or weakness while taking ARRANON. This is because on rare occasions, muscle problems can be serious.

These are not all the side effects associated with ARRANON. Ask your doctor or pharmacist for more information.

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

General Advice about ARRANON

This leaflet summarizes important information about ARRANON. If you have questions or problems, talk with your or your child’s doctor. You can ask your doctor or pharmacist for information about ARRANON that is written for healthcare providers or it is available at www.pharma.us.novartis.com.

Distributed by: Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936

© Novartis

T2019-91

PRINCIPAL DISPLAY PANEL

Arranon® (nelarabine) Injection

Rx Only NDC 0078-0683-06

For I.V. Infusion Only

250 mg/50 mL (5 mg/mL)

Six 50-mL Vials

Novartis

PRINCIPAL DISPLAY PANEL NDC 0078-0683-06
(click image for full-size original)
ARRANON nelarabine injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0683
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NELARABINE (NELARABINE) NELARABINE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0683-06 6 VIAL in 1 CARTON contains a VIAL
1 50 mL in 1 VIAL This package is contained within the CARTON (0078-0683-06)
2 NDC:0078-0683-61 50 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021877 10/05/2016
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2020 Novartis Pharmaceuticals Corporation

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