Tbo-filgrastim

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take lithium (Eskalith CR, Eskalith, Lithobid).

Before you take tbo-filgrastim, tell your doctor if you:

• have sickle cell anemia or other blood problem
• plan to have bone scans or tests
• are allergic to filgrastim (Neupogen) or pegfilgrastim (Neulasta)
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

• If you will be injecting tbo-filgrastim at home, store this medication in the refrigerator at 36° to 46° F, out of the reach of children.
• Tbo-filgrastim syringes can be stored at room temperature (73° to 81° F) for a period of up to 5 days. If not used within 5 days, it may be returned to the refrigerator and stored up to the expiration date.
• Avoid shaking the medication-filled syringe.
• Inspect the solution before use. Only clear solutions with no visible particles should be used.

Call your doctor for instructions if you miss a dose, or miss an appointment for your tbo-filgrastim injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting this medicine in your eyes. If this occurs, rinse your eyes with water and call your doctor right away.

Usual Adult Dose for Neutropenia Associated with Chemotherapy:

5 mcg/kg/day as a single daily subcutaneous bolus injection.

Duration of therapy: Daily dosing should continue until the expected neutrophil nadir is
passed and the neutrophil count has recovered to the normal range.

Comments:
-Avoid administration during the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy.
-Monitor complete blood count (CBC) prior to chemotherapy and twice per week until recovery.

Use: Reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Commonly reported side effects of tbo-filgrastim include: hyperuricemia, increased lactate dehydrogenase, increased leukocyte alkaline phosphatase, increased serum alkaline phosphatase, ostealgia, and thrombocytopenia. Other side effects include: arthralgia, headache, myalgia, and pruritus. See below for a comprehensive list of adverse effects.

Applies to tbo-filgrastim: subcutaneous solution

Along with its needed effects, tbo-filgrastim may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking tbo-filgrastim:

• Bone pain

• Chills
• cough
• eye pain
• fever
• general feeling of illness
• headache
• sore throat
• unusual tiredness

• Bloody or cloudy urine
• chest pain or tightness
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• pain in the upper left part of the stomach or at the tip of the left shoulder
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing
• unusual weakness
• weight gain

Some side effects of tbo-filgrastim may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site