arranon
Pharmaranks rates Arranon 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Arranon (Nelarabine) is a nucleoside metabolic inhibitor used to treat T-Cell Leukemia.
Nelarabine · by Sandoz
Available as a generic: Nelarabine
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Nelarabine
- Drug class
- Nucleoside Metabolic Inhibitor
- Form
- Injectable
- Strength
- Nelarabine 250MG/50ML (5MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- t-cell leukemia
- Manufacturer
- Sandoz
- FDA application
- NDA021877
- FDA boxed warning
- Yes — see the boxed warning
What is Arranon?
From the FDA label:ARRANON (nelarabine) is a prodrug of the cytotoxic deoxyguanosine analogue, 9-β- D -arabinofuranosylguanine (ara-G). The chemical name for nelarabine is 2-amino-9-β- D -arabinofuranosyl-6-methoxy-9 H -purine. It has the molecular formula C 11 H 15 N 5 O 5 and a molecular weight of 297.27. Nelarabine has the following structural formula: Nelarabine is slightly soluble to soluble in water and melts with decomposition between 209ºC and 217ºC. ARRANON (nelarabine) injection is supplied as a clear, colorless, sterile solution in glass single-dose vials. Each vial contains 250 mg of nelarabine (5 mg nelarabine per mL) and the inactive ingredient sodium chloride (4.5 mg per mL) in Water for Injection, USP. ARRANON is intended for intravenous infusion. Hydrochloric acid and sodium hydroxide may have been used to adjust the pH. The solution pH ranges from 5.0 to 7.0. The following structural formula for nelarabine is 2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine. It has the molecular formula C11H15N5O5 and a molecular weight of 297.27.
How to use
Adult Dose : 1,500 mg/m 2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days. ( 2.1 ) • Pediatric Dose : 650 mg/m 2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days. ( 2.1 ) • Discontinue treatment for neurologic reactions greater than or equal to Grade 2. ( 2.2 ) • Dosage may be delayed for hematologic reactions. ( 2.2 ) • Take measures to prevent hyperuricemia. ( 2.4 ) 2.1 Recommended Dosage This product is for intravenous use only. Adult Dosage : The recommended adult dose of ARRANON is 1,500 mg/m 2 administered by intravenous infusion over 2 hours on Days 1, 3, and 5 repeated every 21 days. Administer ARRANON undiluted. Pediatric Dosage : The recommended pediatric dose of ARRANON is 650 mg/m 2 administered by intravenous infusion over 1 hour daily for 5 consecutive days repeated every 21 days. Administer ARRANON undiluted. The recommended duration of treatment for adult and pediatric patients has not been clearly established. In clinical trials, treatment was generally continued until there was evidence of disease progression, the patient experienced unacceptable toxicity, the patient became a candidate for hematopoietic stem cell transplantation (HSCT), or the patient no longer continued to benefit from treatment. 2.2 Dosage Modification Discontinue ARRANON if the patient…
Side effects
The following clinically-significant adverse reactions are discussed in greater detail in other sections of the label: • Neurologic [see Boxed Warning, Warnings and Precautions (5.1)] • Hematologic [see Warnings and Precautions (5.2)] • Tumor Lysis Syndrome [see Warnings and Precautions (5.4)] • Effects on Ability to Drive and Use Machines [see Warnings and Precautions (5.6)] The most common (≥ 20%) adverse reactions were: • Adult : anemia, thrombocytopenia, neutropenia, nausea, diarrhea, vomiting, constipation, fatigue, pyrexia, cough, and dyspnea. ( 6.1 ) • Pediatric : anemia, neutropenia, thrombocytopenia, and leukopenia. ( 6.1 ) The most common (> 10%) neurological adverse reactions were: • Adult : somnolence, dizziness, peripheral neurologic disorders, hypoesthesia, headache, and paresthesia. ( 6.1 ) • Pediatric : headache and peripheral neurologic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory T-ALL and T-LBL ARRANON was studied in 459 patients in Phase I and…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Severe neurologic adverse reactions have been reported with the use of ARRANON ® . These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome [see Warnings and Precautions (5.1)]. Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity during treatment with ARRANON. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater [see Warnings and Precautions (5.1)]. WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. ( 5.1 ) Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater. ( 5.1 )
Warnings
Important safety information
Neurologic Adverse Reactions : Severe neurologic reactions have been reported. Monitor for signs and symptoms of neurologic toxicity. ( 5.1 ) • Hematologic Reactions : Complete blood counts including platelets should be monitored regularly. ( 5.2 ) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception; and advise males to use condoms. ( 5.3 , 8.1 , 8.3 ) • Effects on Ability to Drive and Use Machines : Somnolence may occur. Advise patients to refrain from these activities until somnolence has resolved. ( 5.6 ) 5.1 Neurologic Adverse Reactions Nervous system adverse reactions of any grade were reported for 223 (76%) adult patients across the Phase I and Phase II trials, and Grade 3 or higher (severe, life-threatening, or fatal) adverse reactions were reported for 55 (19%) patients following initiation of ARRANON therapy [see Adverse Reactions ( 6.1 )] . Based on patients with complete data, the median time to onset of first event is 5 days from start of first infusion (range: 1-166), and the median duration is 6 days (range: 1-393 days). Nervous system adverse reactions of any grade were reported for 69 (42%) pediatric patients across the Phase I and Phase II trials, and Grade 3 or higher (severe, life-threatening, or fatal) adverse reactions were reported for 25 (15%) patients following initiation of ARRANON therapy [see Adverse Reactions (6.1)] . Based on patients with complete data, the median time to onset of first event is 8 days from start of first infusion (range: 1-269), and the median duration is 2 days (range: 1-82 days). Common signs and symptoms of ARRANON-related neurotoxicity include somnolence, headache, paresthesia and dysesthesia, dizziness, neuropathy (sensory and motor), cerebellar disturbances and tremor. Severe neurologic toxicity can manifest as coma, status epilepticus, craniospinal demyelination, or ascending neuropathy similar in presentation to Guillain-Barré syndrome. Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events. Monitor patients frequently for signs and symptoms of neurologic toxicity during and for at least 24 hours after completion of treatment with ARRANON. Discontinue ARRANON for neurologic adverse reactions of NCI CTCAE Grade 2 or greater and provide supportive care [see Dosage and Administration ( 2.2 ), Adverse Reactions ( 6.1 )] . 5.2 Hematologic Adverse Reactions Leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia, have been associated with ARRANON therapy. Complete blood counts including platelets should be monitored regularly [see Dosage and Administration (2.2), Adverse Reactions (6.1)] . 5.3 Embryo-Fetal Toxicity Based on its mechanism of action and findings in animal studies, ARRANON can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . In animal reproduction studies, intravenous administration of nelarabine to pregnant rabbits during the period of organogenesis resulted in teratogenicity at maternal doses below the recommended human adult dose of 1,500 mg/m 2 /day (see Data) . Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ARRANON. Advise males with female partners of reproductive potential to use condoms during treatment with ARRANON and for 3 months after the last dose [see Use in Specific Populations (8.1, 8.3), Nonclinical Toxicology (13.1)] . 5.4 Tumor Lysis Syndrome Patients receiving ARRANON should receive intravenous hydration according to standard medical practice for the management of hyperuricemia in patients at risk for tumor lysis syndrome. Consideration should be given to the use of allopurinol in patients at risk of hyperuricemia [see Dosage and Administration ( 2.4 )] . 5.5 Vaccinations Avoid the administration of live vaccines to immunocompromised patients. 5.6 Effects on Ability to Drive and Use Machines Patients treated with ARRANON may experience somnolence during and for several days after treatment [see Adverse Reactions (6.1)] . Advise patients to refrain from driving or engaging in hazardous occupations or activities until somnolence has resolved.
Who should not take Arranon
None. None. (4)
Overdose — what happens if you take too much
There is no known antidote for overdoses of ARRANON. It is anticipated that overdosage would result in severe neurotoxicity (possibly including paralysis, coma), myelosuppression, and potentially death. In the event of overdose, supportive care consistent with good clinical practice should be provided. At a dose of 2200 mg/m 2 given on Days 1, 3, and 5 every 21 days, 2 patients developed a significant Grade 3 ascending sensory neuropathy. Magnetic resonance imaging evaluations of the 2 patients demonstrated findings consistent with a demyelinating process in the cervical spine.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Administration of ARRANON in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3)] . Administration in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended. ( 7 , 12.3 )
Storing Arranon, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “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).”
Drug class
How this class works, per Gemcitabine — LiverTox, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Arranon ranks — best-rated nucleoside metabolic inhibitor for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Arranon treat?
- Arranon (Nelarabine) may be used to treat t-cell leukemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Arranon work?
- Arranon is a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die.
- How is Arranon rated?
- pharmaranks gives Arranon a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Arranon?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Arranon. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Arranon?
- Arranon is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
- Is Arranon a brand-name or generic drug?
- Arranon is a brand-name product with the active ingredient Nelarabine. Lower-cost generic equivalents containing Nelarabine are available — ask your pharmacist.
- Is Arranon available over the counter?
- No. Arranon is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Arranon come in?
- Arranon is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Arranon?
- Arranon is classified as nucleoside metabolic inhibitor, per the FDA's Established Pharmacologic Class.
- Is Arranon FDA-registered?
- Arranon is on record with the U.S. FDA under application number NDA021877. You can verify this on its official FDA label.
- Has Arranon been recalled by the FDA?
- Arranon has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Arranon safe?
- There's no single safe-or-not verdict. pharmaranks gives Arranon a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Arranon?
- Arranon's side effects are taken directly from its FDA label. From the label: The following clinically-significant adverse reactions are discussed in greater detail in other sections of the label: • Neurologic [see Boxed Warning, Warnings and Precautions (5.1)] • Hematologic [see Warnings and Precautions (5.2)] • Tumor Lysis Syndrome [see Warnings and Precautions (5.4)] • Eff… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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arranon
68/100