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Prescribing Information &
Medication Guide		 Important Safety
Information		 The Nplate® NEXUS
Program

Glossary1

Antibody: A protein made by the body's immune system to attack foreign cells. In ITP, antibodies attack the body's own platelets.

Autoimmune disease: A disease in which the body's own immune system attacks an otherwise healthy part of the body.

Bone marrow: Tissue inside the bones where blood cells are made.

Co-insurance: Some insurance coverage requires you to pay a percentage of the cost of covered medical services, usually 20-30 percent. Your portion of the cost is the co-insurance.2

Co-payment: A flat fee for specified medical services required by some insurers. For example, you pay a $10 co-payment for a doctor visit or a $50 co-payment for a hospital stay.2

Idiopathic (id-ee-oh-path-ick): Not having a known cause.

Immune (idiopathic) thrombocytopenic purpura (ITP): An autoimmune disease in which the body's immune system attacks and destroys platelets. ITP can stand for either immune thrombocytopenic purpura or idiopathic thrombocytopenic purpura. These are two names for the same disease.

Megakaryocyte (meg-ah-carry-oh-sight): Cells in the bone marrow that make platelets.

Menorrhagia: Heavy menstrual bleeding.

Out-of-pocket maximum: The amount of co-insurance a member must pay before out-of-network claims will be paid at 100% of the allowed amount.2

Petechiae: Red or purple spots on the skin. A common symptom of a low platelet count.

Platelet count: A measure of how many platelets are in the blood, usually expressed in thousands per microliter (eg, 50,000) or in 109 per liter (eg, 50 x 109/L). A count of 50 x 109/L is equal to a count of 50,000 per microliter.

Platelets: Small cells that are made in the bone marrow and circulate through the bloodstream. Whenever there is damage to a blood vessel, platelets cling to the area to help heal the damage and to stop or prevent bleeding.

Purpura: Red or purple spots on the skin, larger than petechiae. These are signs of bleeding underneath the skin and are a common symptom of a low platelet count.

Splenectomy (splen-echt-ta-me): A surgical procedure that removes the spleen.

Subcutaneous (sub-q-tain-ee-us): An injection under the skin.

Thrombocytopenia (throm-bo-sigh-toe-peen-knee-a): The general term for having platelet counts lower than 150,000 per microliter. Thrombocytopenia can have a number of different causes. ITP is only one cause of thrombocytopenia.

Thrombopoietin (throm-bo-po-eat-in) (TPO): The protein that stimulates the megakaryocytes in the bone marrow to produce platelets.
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Indication

Nplate® is a man-made protein medicine used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) when other medicine to treat your ITP is not the best choice for you or surgery to remove the spleen has not worked well enough. Nplate® is used to try to keep your platelet count about 50,000 per microliter in order to lower the risk for bleeding. Nplate® is not used to make your platelet count normal.

Important Safety Information

What is the most important information I should know about Nplate®?

Nplate® can cause uncommon but serious side effects:

Bone marrow changes (increased reticulin and possible bone marrow fibrosis). Long-term use of Nplate® may cause changes in your bone marrow. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called "increased reticulin." It is not known if this may progress to a more severe form called "fibrosis." The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormalities in your blood tests. Your healthcare provider will decide if abnormal blood tests mean that you should have bone marrow tests or if you should stop taking Nplate®.

Worsening low blood platelet count (thrombocytopenia) and risk of bleeding shortly after stopping Nplate®. When you stop receiving Nplate®, your low blood platelet count (thrombocytopenia) may become worse than before you started receiving Nplate®. These effects are most likely to happen shortly after stopping Nplate® and may last about 2 weeks. The lower platelet counts during this time period may increase your risk of bleeding, especially if you are taking a blood thinner or other medicine that affects platelets. Your healthcare provider will check your blood platelet counts for at least two weeks after you stop taking Nplate®. Call your healthcare provider right away to report any bruising or bleeding.

High platelet counts and higher chance for blood clots. You have a higher chance of getting a blood clot if your platelet count is too high during treatment with Nplate®. You may have severe complications or die from some forms of blood clots, such as clots that spread to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts and change your dose or stop Nplate® if your platelet counts get too high.

Worsening of blood cancers. Nplate® is not for use in patients with blood cancer or a precancerous condition called myelodysplastic syndrome (MDS). If you have one of these conditions, Nplate® may worsen your cancer or condition and may cause you to die sooner.

Lack or loss of response: If you do not experience results from Nplate® your body may have created cells that are counteractive to Nplate®. Your healthcare provider will monitor your platelet counts and test your blood regularly to determine if this is an issue. Your healthcare provider will check your platelet count every week and change your dose of Nplate® as needed. This will continue until your healthcare provider decides that your dose of Nplate® can stay the same. After that, you will need to have blood tests every month. When you stop receiving Nplate®, you will need blood tests for at least 2 weeks to check if your platelet count drops too low.

Nplate® is only:
Prescribed by healthcare providers who are enrolled in the Nplate® NEXUS Program.
Given to patients who are enrolled in the Nplate® NEXUS Program.
Given by the enrolled healthcare provider or a provider under their direction. You may not give Nplate® injections to yourself.
Nplate® is for treatment of certain people with low blood platelet counts caused by chronic ITP, not low platelet counts caused by other conditions or diseases.

What are the possible side effects of Nplate®?
Nplate® may cause serious side effects. See "What is the most important information I should know about Nplate®?"

The most common side effects of Nplate® are:
  • Headache
  • Joint pain
  • Dizziness
  • Trouble sleeping
  • Muscle tenderness or weakness
  • Pain in arms and legs
  • Abdominal pain
  • Shoulder pain
  • Indigestion
  • Tingling or numbness in hands and feet
These are not all the possible side effects of Nplate®. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist.

If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.You may also report side effects to the Nplate® NEXUS Program at 1-877-NPLATE1 (1-877-675-2831).

Please see full Prescribing Information and Medication Guide for more information about Nplate®.

1. MedlinePlus medical dictionary. http://www.nlm.nih.gov/medlineplus/mplusdictionary.html. Accessed March 25, 2009. 2. New York State Insurance Department. Health Insurance: Glossary of Terms. http://www.ins.state.ny.us/website1/inshelp/c_hterm.htm. Accessed March 25, 2009.
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