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WHY VITAMIN B12 IS IMPORTANT

Vitamin B12 is an essential vitamin. Everyone needs it to stay healthy. Vitamin B12 helps your body work properly. It protects your nerve cells so they can grow the right way. Vitamin B12 also helps make red blood cells, which give oxygen to the tissues in your body.

THERE ARE MANY CAUSES FOR VITAMIN B12 DEFICIENCY

  • Celiac disease
  • Heavy drinking
  • Strict vegetarian or vegan diet
  • Long-term use of certain medications such as metformin and proton pump inhibitors
  • Immune system disorders
  • HIV infection
  • Crohn’s disease
  • Atrophic gastritis
  • Gastric surgery
  • Hypothyroidism

SYMPTOMS OF VITAMIN B12 DEFICIENCY ARE NON-SPECIFIC

Symptoms may include:

  • Diarrhea or constipation
  • Fatigue, lack of energy, or lightheadedness when standing up or with exertion
  • Loss of appetite
  • Pale skin
  • Problems concentrating
  • Shortness of breath, mostly during exercise
  • Swollen, red tongue or bleeding gums
  • Numbness and tingling of hands and feet
  • Confusion or change in mental status
  • Loss of balance

Talk to your doctor about being screened for vitamin B12 deficiency.

What is NASCOBAL® NASAL SPRAY?

The only FDA-APPROVED prescription vitamin B12 nasal spray

NASCOBAL® (Cyanocobalamin, USP) Nasal Spray is a prescription medicine used as a supplement to treat vitamin B12 deficiency. It is designed to bypass the GI tract and be absorbed directly into the bloodstream. It is clinically proven to have increased and maintained healthy vitamin B12 blood levels. NASCOBAL® is a tasteless and odorless fine mist with a convenient, once-weekly dosing regimen:

1 spray, 1 nostril, 1x a week.

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Product shown may not be actual size.

Do not drink hot liquids or eat hot foods at least 1 hour before and 1 hour after taking NASCOBAL® Nasal Spray.

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

Clinical data

In 21 healthy volunteers under fasting conditions, a single 500-mcg dose of NASCOBAL® was given and monitored for 3 days.

Vitamin B12 OPTIONS

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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

How to Use NASCOBAL® NASAL SPRAY

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nasal-spray-step1
  • 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
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  • 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
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  • 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
Do not drink hot liquids or eat hot foods at least 1 hour before and 1 hour after taking NASCOBAL® Nasal Spray.

Patient RESOURCES

ELIGIBLE PATIENTS MAY PAY AS LITTLE AS $0 PER MONTH FOR NASCOBAL®

Save on NASCOBAL® with the $0 Copay Card.

Download Copay Cardnascobal-copay-card

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.

patient-ed-brochure

Download the NASCOBAL® Patient Brochure to learn more about treating vitamin B12 deficiency with NASCOBAL® Nasal Spray.

Download Brochure

WHAT IS NASCOBAL®?

NASCOBAL® is a prescription medicine used:

  • For maintenance therapy to treat vitamin B12 deficiency (low levels of vitamin B12) in adults with pernicious anemia who achieved healthy vitamin B12 levels after receiving vitamin B12 shots and do not have nervous system problems.
  • To treat vitamin B12 deficiency caused by:
    • certain food limitations,
    • other medicines that cause vitamin B12 deficiency, or
    • lack of absorption (malabsorption) that are not related to pernicious anemia.
  • To prevent vitamin B12 deficiency in adults that need to increase their levels of vitamin B12 higher than normal levels.

NASCOBAL® should not be used for a vitamin B12 absorption test known as the Schilling test.

In people who have corrected or have fixed their short-term causes of vitamin B12 deficiency, the benefit of continued long-term use of NASCOBAL® is not known after vitamin B12 deficiency has been corrected.

It is not known if NASCOBAL® is effective in people who currently have a stuffy nose, allergies or an upper respiratory infection. You should wait until these symptoms have gone away before using NASCOBAL®.

It is not known if NASCOBAL® is safe and effective in children.

IMPORTANT SAFETY INFORMATION FOR NASCOBAL®

Do not use NASCOBAL® if you are allergic to cobalt, vitamin B12, or any of the ingredients in NASCOBAL®.

NASCOBAL® can cause serious side effects, including:

  • Weakening of your eye nerve in patients with early Leber’s disease. Tell your healthcare provider if you or your family has a history of early Leber’s disease.
  • Serious allergic reactions. Serious, life-threatening allergic reactions, including death, have happened in people who have received vitamin B12 by injection or by intravenous (IV) infusion (parenteral). Tell your healthcare provider if you have ever had a reaction after you received vitamin B12 by injection or IV infusion.
  • Hiding (masking) a folate deficiency. Your healthcare provider may do certain blood tests to check your vitamin B12 and folate levels.
  • Low potassium levels (hypokalemia) and low blood platelets (thrombocytopenia) can happen in people with serious megaloblastic anemia. Your healthcare provider may monitor your potassium levels and platelet counts during your treatment with NASCOBAL®.

Vitamin B12 deficiency may hide signs of a blood condition called polycythemia vera. Treatment with NASCOBAL® may uncover this condition.

Tell your doctor if you are pregnant or planning to become pregnant (it is not known if NASCOBAL® will harm your unborn baby).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects include infection, headache, feeling weak, nausea, swelling of your tongue, runny nose, tingling of the hands and feet.

These are not all the possible side effects of NASCOBAL®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information.

WHAT IS NASCOBAL®?

NASCOBAL® is a prescription medicine used:

  • For maintenance therapy to treat vitamin B12 deficiency (low levels of vitamin B12) in adults with pernicious anemia who achieved healthy vitamin B12 levels after receiving vitamin B12 shots and do not have nervous system problems.
  • To treat vitamin B12 deficiency caused by:
    • certain food limitations,
    • other medicines that cause vitamin B12 deficiency, or
    • lack of absorption (malabsorption) that are not related to pernicious anemia.
  • To prevent vitamin B12 deficiency in adults that need to increase their levels of vitamin B12 higher than normal levels.

NASCOBAL® should not be used for a vitamin B12 absorption test known as the Schilling test.

In people who have corrected or have fixed their short-term causes of vitamin B12 deficiency, the benefit of continued long-term use of NASCOBAL® is not known after vitamin B12 deficiency has been corrected.

It is not known if NASCOBAL® is effective in people who currently have a stuffy nose, allergies or an upper respiratory infection. You should wait until these symptoms have gone away before using NASCOBAL®.

It is not known if NASCOBAL® is safe and effective in children.

IMPORTANT SAFETY INFORMATION FOR NASCOBAL®

Do not use NASCOBAL® if you are allergic to cobalt, vitamin B12, or any of the ingredients in NASCOBAL®.

NASCOBAL® can cause serious side effects, including:

  • Weakening of your eye nerve in patients with early Leber’s disease. Tell your healthcare provider if you or your family has a history of early Leber’s disease.
  • Serious allergic reactions. Serious, life-threatening allergic reactions, including death, have happened in people who have received vitamin B12 by injection or by intravenous (IV) infusion (parenteral). Tell your healthcare provider if you have ever had a reaction after you received vitamin B12 by injection or IV infusion.
  • Hiding (masking) a folate deficiency. Your healthcare provider may do certain blood tests to check your vitamin B12 and folate levels.
  • Low potassium levels (hypokalemia) and low blood platelets (thrombocytopenia) can happen in people with serious megaloblastic anemia. Your healthcare provider may monitor your potassium levels and platelet counts during your treatment with NASCOBAL®.

Vitamin B12 deficiency may hide signs of a blood condition called polycythemia vera. Treatment with NASCOBAL® may uncover this condition.

Tell your doctor if you are pregnant or planning to become pregnant (it is not known if NASCOBAL® will harm your unborn baby).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects include infection, headache, feeling weak, nausea, swelling of your tongue, runny nose, tingling of the hands and feet.

These are not all the possible side effects of NASCOBAL®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information.