THE ONLY FDA-APPROVED PRESCRIPTION VITAMIN B12 NASAL SPRAY1

  • Designed to bypass the GI tract and be absorbed directly into the bloodstream2
  • Absorption of vitamin B12 in the GI tract mainly depends on intrinsic factor, which is secreted by the gastric mucosa3
b12-deficiency-prevalence

Risk factors that can lead to vitamin B12 deficiency5:

  • Celiac disease6,7
  • Heavy drinking
  • Strict vegetarian or vegan diet
  • Long-term use of certain medications such as metformin and proton pump inhibitors
  • Immune system disorders8
  • HIV infection8
  • Crohn's disease
  • Atrophic gastritis
  • Gastric surgery
  • Hypothyroidism9

CLINICAL DATA

Clinically proven to have increased vitamin B12 levels from the first dose10

vitamin-b12-mean-concentration
  • Achieved mean peak serum vitamin B12 concentration within 1.5 hours10*
  • Reached mean peak concentration of 1021 pg/mL10*
  • At 72 hours, mean serum vitamin B12 level was increased by 46% above baseline10*

In 21 healthy volunteers under fasting conditions, a single 500-mcg dose of NASCOBAL® was given and monitored for 3 days. Data are based on baseline uncorrected serum vitamin B12 levels.

Intranasal Administration Has Maintained Healthy Vitamin B12 Levels

serum-b12-mean
  • Once-a-week Intranasal Dosing maintained higher serum vitamin B12 levels than 1 intramuscular vitamin B12 injection after 28 days

In 24 patients with a history of pernicious anemia, a single-dose cyanocobalamin 100-mcg IM injection was given and monitored for 28 days, followed by 4 once-weekly doses of intranasal (IN) vitamin B12 gel 500 mcg/0.1 mL. Mean baseline serum vitamin B12 prior to IN dosing = 351.4 pg/mL, and at day 28 = 480.7 pg/mL.11

In a separate study, bioavailability of vitamin B12 nasal spray was 10% less than vitamin B12 nasal gel. Clinical significance is unknown.12

HOW TO USE NASCOBAL® NASAL SPRAY

CONVENIENT, ONCE-WEEKLY DOSING REGIMEN

Self-administered: 1 spray, 1 nostril, 1x a week12

  • Convenient, once-weekly dosing regimen
  • Each single-use device delivers one 500-mcg dose
  • Tasteless and odorless fine mist

A simple single-use device

nasal-spray-step1-hcp
  • The unit contains only 1 spray:
    DO NOT prime before use
  • Blow nose gently to clear both nostrils
  • Hold the unit with your thumb, supporting it at the bottom, and your index and middle fingers on either side of the nozzle
nasal-spray-step2-hcp
  • Gently close 1 nostril with your other index finger. Insert the nozzle into open nostril approximately ½ inch, or as far as feels comfortable, and tilt your head slightly forward. Do not press the plunger yet
  • Breathe in gently through your nose, close your mouth, and at the same time, press the plunger firmly with your thumb
nasal-spray-step3-hcp
  • Remove the nozzle from your nostril. At the same time, keep your head level for 10 to 20 seconds while gently breathing in through your nose and breathing out through your mouth
NASCOBAL® Nasal Spray should be administered at least one hour before or one hour after ingestion of hot foods or liquids.

Dose adjustments may be required.

PHYSICIAN RESOURCES

AN AFFORDABLE TREATMENT FOR VITAMIN B12 DEFICIENCY

Eligible patients may get NASCOBAL® for as little as $0 per month.
EASY ENROLLMENT FOR PHYSICIANS AND PATIENTS
  1. Patient completes top half of form.
  2. Prescriber signs preprinted prescription at bottom of form.
  3. Office faxes completed form to specialty pharmacy.
E-prescribing is available — ask your Endo Representative for details.
Download the NASCOBAL® Patient Brochure to learn more about treating vitamin B12 deficiency with NASCOBAL® Nasal Spray.

Patients may redeem this offer ONLY when accompanied by a valid prescription. Offer is valid up to a maximum benefit of $130. Offer is not valid for patients whose prescriptions are reimbursed in whole or in part under Medicaid, Medicare, Medigap, VA, DoD, TRICARE, or any other federal or state programs (such as medical assistance programs) or where otherwise prohibited by law. Offer is not valid in VT or where prohibited in whole or in part. This offer may be amended or ended at any time without notice.

VITAMIN B12 OPTIONS

NASCOBAL®
Nasal Spray
FDA-approved
Prescription
Once-a-week dosing
Odorless
Tasteless
Can be taken at home
Not an injection
SUBLINGUAL
(under-the-tongue)
Can be taken at home
Not an injection
INJECTIONS
 
FDA-approved
Prescription
Odorless
Tasteless

IMPORTANT SAFETY INFORMATION FOR NASCOBAL® NASAL SPRAY

NASCOBAL® is contraindicated in patients with sensitivity to cobalt, vitamin B12, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B12. Consider administering an intradermal test dose of parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity prior to starting NASCOBAL®.

Patients with Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy. NASCOBAL® is not recommended for use in patients with Leber’s optic atrophy.

Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate-deficient megaloblastic anemia, and may therefore mask a previously unrecognized folate deficiency. NASCOBAL® is not a substitute for folic acid. Assess both vitamin B12 and folate levels prior to initiating therapy with NASCOBAL®.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Serum potassium levels and platelet count should be monitored.

Treatment with vitamin B12 may unmask signs of polycythemia vera. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation.

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Consider the potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays. Vitamin B12 and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL®, consider alternative therapy.

If NASCOBAL® is used concomitantly with chloramphenicol, monitor for reduced efficacy and, if needed, consider an alternative therapy.

The limited available data on NASCOBAL® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

The most common adverse reactions (≥4%) were infection, headache, glossitis, paresthesia, asthenia, nausea and rhinitis.

INDICATIONS

  • Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement
  • Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia
  • Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal

Limitations of Use

  • NASCOBAL® should not be used for the vitamin B12 absorption test (Schilling test).
  • In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long-term use of NASCOBAL® following adequate correction of vitamin B12 deficiency and underlying disease has not been established.
  • The effectiveness of NASCOBAL® in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with NASCOBAL® should be deferred until symptoms have subsided.
Please see the full Prescribing Information.

IMPORTANT SAFETY INFORMATION FOR NASCOBAL® NASAL SPRAY

NASCOBAL® is contraindicated in patients with sensitivity to cobalt, vitamin B12, or any component of the medication. Anaphylactic shock and death have been reported with parenteral forms of vitamin B12. Consider administering an intradermal test dose of parenteral vitamin B12 to patients suspected of cyanocobalamin hypersensitivity prior to starting NASCOBAL®.

Patients with Leber's disease who were treated with vitamin B12 suffered severe and swift optic atrophy. NASCOBAL® is not recommended for use in patients with Leber’s optic atrophy.

Doses of vitamin B12 exceeding 10 mcg daily may produce hematologic response in patients with folate-deficient megaloblastic anemia, and may therefore mask a previously unrecognized folate deficiency. NASCOBAL® is not a substitute for folic acid. Assess both vitamin B12 and folate levels prior to initiating therapy with NASCOBAL®.

Hypokalemia, thrombocytosis and sudden death may occur in severe megaloblastic anemia which is treated intensely with vitamin B12. Serum potassium levels and platelet count should be monitored.

Treatment with vitamin B12 may unmask signs of polycythemia vera. Patients exhibiting clinical or hematologic response consistent with polycythemia vera should be referred for further evaluation.

Hematocrit, reticulocyte count, vitamin B12, folate and iron levels should be obtained prior to treatment. Consider the potential for concomitant drugs to interfere with vitamin B12 and folate diagnostic blood assays. Vitamin B12 and peripheral blood counts must be monitored initially at one month after the start of treatment, and then at intervals of 3 to 6 months. If a patient is not properly maintained with NASCOBAL®, consider alternative therapy.

If NASCOBAL® is used concomitantly with chloramphenicol, monitor for reduced efficacy and, if needed, consider an alternative therapy.

The limited available data on NASCOBAL® in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

The most common adverse reactions (≥4%) were infection, headache, glossitis, paresthesia, asthenia, nausea and rhinitis.

INDICATIONS

  • Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement
  • Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia
  • Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal

Limitations of Use

  • NASCOBAL® should not be used for the vitamin B12 absorption test (Schilling test).
  • In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long-term use of NASCOBAL® following adequate correction of vitamin B12 deficiency and underlying disease has not been established.
  • The effectiveness of NASCOBAL® in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with NASCOBAL® should be deferred until symptoms have subsided.
Please see the full Prescribing Information.