GRANIX- tbo-filgrastim injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Summary of Product characteristics (SPC)

30-11-2023

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Active ingredient:

FILGRASTIM (UNII: PVI5M0M1GW) (FILGRASTIM - UNII:PVI5M0M1GW)

Available from:

Cephalon, LLC

INN (International Name):

FILGRASTIM, LICENSE HOLDER UNSPECIFIED

Composition:

FILGRASTIM, LICENSE HOLDER UNSPECIFIED 300 ug in 0.5 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX is contraindicated in patients with a history of serious allergic reactions to filgrastim products or pegfilgrastim products [see Warnings and Precautions (5.3) ]. Risk Summary The limited published data on filgrastim product use during pregnancy are insufficient to inform a drug-associated risk. In animal reproduction studies, administration of tbo-filgrastim to pregnant rabbits during organogenesis resulted in increased spontaneous abortion and fetal malformations at systemic exposures 50 to 90 times the human exposure expected at the recommended human dose (see Data) . GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day. Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day. This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hind limbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC) of approximately 50 to 90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day. No data are available regarding the presence of tbo-filgrastim in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Another filgrastim product was detected in human milk for up to 3 days after filgrastim administration. Because of the potential for serious adverse reactions in the breastfed child, including splenic rupture, acute respiratory distress syndrome and serious allergic reactions, advise patients not to breastfeed during treatment with GRANIX and for 2 weeks after the last dose. The safety and effectiveness of GRANIX have been established for pediatric patients 1 month to < 17 years old (no data for the age group < 1 month old). Use of GRANIX in these age groups is supported by evidence from adequate and well-controlled studies of GRANIX in adults [see Clinical Studies (14)] with additional safety and pharmacokinetics data from a single-arm trial of 50 pediatric patients with solid tumors treated with GRANIX for chemotherapy-induced neutropenia. The 50 pediatric patients had a median age of 9.2 years (range, 1.4 to 15.9 years); 2 were infants (1 month to < 2 years old), 30 were children (2 to < 12 years old), and 18 were adolescents (12 to < 17 years old). The pharmacokinetics and safety profile of GRANIX in the pediatric population were similar to those seen in adults [see Adverse Reactions (6.1), Clinical Pharmacology (12.3)] . Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older, and 14 patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients. GRANIX (GRAN-icks) (tbo-filgrastim) for subcutaneous injection Single-Dose Prefilled Syringe Important: Read the Prescribing information and Patient Package insert for important information about GRANIX. About the GRANIX syringe Depending on the prescription that your healthcare provider gave you, you will receive a syringe that provides a dose of either 0.1 mL to 0.5 mL or 0.1 mL to 0.8 mL. If you are prescribed a dose over 0.8 mL, two syringes will be required to reach your prescribed dose. Your healthcare provider will determine how many syringes and the correct dose in milliliters (mL) you will need to give based on your body weight. You should continue to give GRANIX daily until your healthcare provider informs you that your white blood cell count has returned to normal. Make sure you understand the following: - How to store your syringes. - How to read the syringe markings. - How to adjust the amount of GRANIX in the syringe for your prescribed dose. - How to prepare and give the injection. Do not shake syringes. Do not remove the needle cap until you are ready to inject. Do not re-use a syringe. The syringe is for single-use only. Your first dose of GRANIX is given at least 24 hours after you receive your chemotherapy. Do not inject GRANIX within 24 hours before your next dose of chemotherapy. Dosing schedule Inject your total daily dose 1 time each day as prescribed by your healthcare provider, starting at least 24 hours (1 day) after the end of your chemotherapy cycle. You should continue to give GRANIX daily until your white blood cell count returns to normal. How to store your GRANIX syringes - Store GRANIX in the refrigerator between 36°F to 46°F (2°C to 8°C). - Store GRANIX in the original carton to protect it from light. - Do not shake. - Take GRANIX out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. - GRANIX syringes can be left at room temperature for a single period of up to 5 days, and if not used can be returned to the refrigerator. Throw away (dispose of) any GRANIX syringes that have been left at room temperature for more than 5 days. - After you inject your dose, throw away (dispose of) any unused GRANIX left in the syringe. Do not save unused GRANIX in the syringe for later use. Keep GRANIX and all medicines out of the reach of children. Determining how many syringes you need for your daily dose - If your prescribed daily dose is 0.5 mL or less, use 1 syringe. - If your prescribed daily dose is 0.8 mL or less, use 1 syringe. - If your prescribed daily dose is more than 0.8 mL you will need to prepare 2 syringes in order to match your prescribed dose: Adjust your first syringe to 0.8 mL. Adjust your second syringe to the additional amount required to make up your total prescribed dose. Make sure the amounts in both syringes add up to your prescribed dose (See the table to the right to determine how much medicine should be in each syringe). - Adjust your first syringe to 0.8 mL. - Adjust your second syringe to the additional amount required to make up your total prescribed dose. - Make sure the amounts in both syringes add up to your prescribed dose (See the table to the right to determine how much medicine should be in each syringe). For example: If your prescribed dose is 1 mL you would prepare 1 syringe with 0.8 mL and a second syringe with 0.2 mL. Important : When using 2 syringes always adjust the first syringe to 0.8 mL. How to read the syringe markings What the markings on the syringe mean: The syringe is labeled in 0.1 mL unit increments from 0.1 mL to 0.8 mL. There is a line next to each 0.1 mL unit increment. To read the dose scale always hold the syringe with the needle-end facing up so that 0.1 mL is at the top and 0.8 mL is at the bottom. How to adjust the medicine level for your prescribed dose - When setting your dose, (See 2C ) you will line up the top edge of the grey rubber stopper with the line on the syringe scale that matches your prescribed dose. - Note : The top edge of the grey rubber stopper is the edge directly below the dome at the top of the stopper. Do not use the top of the cone or the middle or lower edges of the grey stopper to measure your dose. Injection steps (follow the steps below for each day of dosing) 1. Prepare for injection 1A Each time you inject a dose gather the following supplies: - GRANIX syringe(s) - Alcohol swabs - Paper towel - Cotton ball or gauze pad - Adhesive Bandage, if needed - Sharps disposal container (hard-walled container for discarding syringes) Note: GRANIX and all of the parts of the prefilled syringe do not contain natural rubber latex. 1B Take the carton with the syringe(s) out of the refrigerator 1C Check the label and the expiration date on the side of the carton Important: Do not inject if: - “GRANIX® (tbo-filgrastim)” is not listed on the carton. - The expiration date on the syringe label has passed. 1D Remove the syringe(s) from the carton Open the carton by breaking the tamper proof seal and lifting the lid. Remove the number of syringes required for your daily dose by grasping each at the middle of the syringe body. After removing your required number of syringes, place the carton back in the refrigerator. 1E Look carefully at the syringe(s) and the medicine Hold the syringe body and check to make sure it is not damaged. Inspect the medicine in the syringe. GRANIX should be a clear liquid. Important: Do not inject if: - GRANIX® (tbo-filgrastim) is not listed on the syringe label. - The medicine is cloudy, discolored, or foamy. - The medicine contains lumps, flakes, or particles. 1F Wait 30 minutes for the syringe(s) to warm to room temperature Wait 30 minutes for GRANIX to naturally warm to room temperature. This will provide a more comfortable injection. 1G Wash your hands When ready to inject, wash your hands with soap and warm water and dry thoroughly with a clean towel. 1H Choose an injection site The recommended injection sites are: If you are self-injecting: Stomach-area (abdomen): Except for a 2-inch area around the navel (belly button). Thighs: Top or middle area of thighs. If a caregiver is injecting GRANIX for you: Arms: Fleshy areas on upper, back part of the arm. Upper hip or buttock: Fleshy areas around the back of the upper hips and upper sides of the buttocks. If 2 injections will be performed, then the second injection should be at least 1 inch away from the first injection. Choose Injection Site Do not inject into areas that are tender, red, bruised, hard, or have scars or stretch marks. Important: - You should select a different injection site each time you give yourself an injection. - If you want to use the same injection site for a dose requiring 2 injections, make sure the second injection site is at least 1 inch away from the first injection site. 1I Clean the injection site using an alcohol swab Allow site to dry for 5-10 seconds to avoid stinging. If giving 2 injections, then the distance between the 2 injection sites should be at least 1 inch apart. Do not touch or blow on site after cleaning. 2. Adjust medicine level for your prescribed dose 2A Remove the needle cap from the syringe Place a paper towel on the table. To remove the needle cap, hold the body of the syringe firmly with 1 hand (with the needle facing away from you). Pull the needle cap straight off, extending your hand away from the needle. Note: Throw away the needle cap in a sharps disposal container. Do not recap the needle now or after the injection. 2B Hold the syringe upright and tap Hold the syringe upright (needle pointing up), as shown. Gently tap the barrel with your fingers to make sure any air bubbles rise to the top. 2C Slowly and carefully adjust the medicine level Hold the syringe with the needle pointing up and slightly away from you , as shown. Make sure you can easily see the syringe markings and numbers. Holding the plunger as shown, very slowly and carefully push the plunger up until the top edge of the grey rubber stopper is even with the line that corresponds to your prescribed dose. Note: - If GRANIX gets on your skin, wash your skin with soap and water. - If GRANIX get in your eyes, flush well with water. Note: If you accidentally removed too much GRANIX, contact your healthcare provider before giving your injection. 3. INJECT MEDICATION 3A Pinch skin The illustration below is an example only Use your free hand to firmly pinch the skin you previously cleaned. 3B Insert the needle at a 45 to 90 degree angle Hold the body of the syringe between your thumb and index finger. Use a quick motion to fully insert the needle straight into the pinched skin at a 45 to 90 degree angle. When the needle is inserted, you can release the pinched skin. Do not hold or push on the plunger while inserting the needle into the skin. 3C Push the plunger down to inject all of the GRANIX Use your finger to gently push down on the plunger. When the plunger head is as far down as it will go, all of the GRANIX has been injected. When done, gently remove the needle from the skin. 3D Throw away (dispose of) used syringe Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. 3E Treat the injection site if needed and wash your hands If you see drops of blood at the injection site, you can press a cotton ball or gauze over the injection site for several seconds to stop the bleeding. Apply bandage, if needed. When you are finished, wash your hands with soap and warm water and dry thoroughly with a clean towel. 4. Repeat the injection steps with the second syringe (If dose is more than 0.8 mL) If your dose is more than 0.8 mL: - Follow instructions 3A through 3E for injecting. - Choose a different site for your second injection. If you want to use the same part of your body, make sure the second injection site is at least 1 inch away from the first injection site. If you have any questions or concerns about your dose of GRANIX or how to prepare and give your injections, call your healthcare provider. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: UAB Teva Baltics Vilnius, Lithuania U.S. License No. 1803 Distributed by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Product of Israel Revised: 11/2023 TBOIFU-004 ©2023 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. INSTRUCTIONS FOR USE GRANIX (GRAN-icks) (tbo-filgrastim) for subcutaneous injection Single-Dose Vial Important: Read the Prescribing information and Patient Package insert for important information about GRANIX. Before you use a GRANIX vial, read this important information: - GRANIX vial is supplied as either 300 mcg in 1 mL solution, or 480 mcg of tbo-filgrastim in 1.6 mL solution. Your healthcare provider will determine which strength of GRANIX to prescribe for you. Your healthcare provider will prescribe the correct number of vials, and the dose in milliliters (mL) that you will need to inject based on your body weight. - When you receive your vials of GRANIX at the pharmacy, check the label to be sure that the dose strength on the vial matches the dose strength that your healthcare provider prescribed for you. If you are not sure, ask your pharmacist. - If you are told that more than 1 injection is needed for each dose of GRANIX, the total dose should be divided into two equal parts. Each of the two parts of your dose should be drawn from a separate vial. - Your healthcare provider will show you how to measure the correct dose of GRANIX before you try to inject it for the first time. This dose will be measured in milliliters (mL). How to store your GRANIX vial - Store GRANIX in the refrigerator between 36°F to 46°F (2°C to 8°C). - Keep GRANIX vials away from light to protect it. If your GRANIX vial comes in a carton, keep it in the carton until you are ready to use it to protect from light. - Do not freeze. - Take GRANIX out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection. - GRANIX vials can be left at room temperature for a single period of up to 5 days, and if not used can be returned to the refrigerator to use later. Throw away (dispose of) any GRANIX vials that have been left at room temperature for more than 5 days. - After you inject your dose, properly dispose of any unused GRANIX left in the vial. Do not save unused GRANIX for later use. Keep GRANIX and all medicines out of the reach of children. Using your vial - It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider. - Make sure that the name GRANIX appears on the carton and vial label. - Check the label and the expiration date on the side of the carton. Do not use a vial after the expiration date on the label. - Do not shake the vial. - Do not use the vial if the medicine is cloudy or discolored, or contains flakes or particles. Do not inject your first dose of GRANIX until at least 24 hours after you receive your chemotherapy. You should continue to receive GRANIX daily until your healthcare provider tells you that your white blood cell count has returned to normal. Do not inject GRANIX less than 24 hours before your next dose of chemotherapy. Call your healthcare provider if you have any questions. Follow the steps below for each day of dosing STEP 1: Prepare Step 1A: Remove GRANIX from the refrigerator Take the GRANIX® (tbo-filgrastim) carton out of the refrigerator. Open the carton by lifting the lid and breaking the seal. Step 1B: Check the label and the expiration date on the carton - Check to make sure "GRANIX® (tbo-filgrastim)” is listed on the carton - Do not use if the expiration date on the carton has passed Remove the number of vials needed for the daily dose. Return the carton containing any unused vials to the refrigerator. Step 1C: Wait 30 minutes for the vials to reach room temperature. Place the vials of GRANIX on a clean, well-lit flat work surface for about 30 minutes to warm to room temperature. This will help to provide a more comfortable injection. - Do not try to warm the vial by using a heat source such as hot water or microwave - Protect the vial from light - Do not shake the vial - Use a vial only 1 time. Step 1D: Inspect the vial Hold each vial and check to make sure it is not damaged. Inspect the medicine in the vial. Make sure the medicine in the vial is clear and colorless. - Check to make sure GRANIX is listed on the vial label. - Do not use the vial if: - The medicine is cloudy or discolored, or contains flakes or particles. - The expiration date on the vial label has passed - In these cases, use a new vial and call your healthcare provider. Step 1E: Gather the following supplies needed for each injection and place them on your clean work surface (Figure A): - 1 GRANIX vial - 1 disposable syringe and needles - 2 alcohol swabs - 1 cotton balls or gauze pad(s) - 1 adhesive bandage(s), if needed - 1 sharps disposal container - Only use disposable syringes and needles that your healthcare provider prescribes. - Only use the syringes and needles 1 time. Throw away (dispose of) any used syringes and needles in a sharps disposal container. - You should only use syringes that are marked in tenths of milliliters (mL). - Your healthcare provider will show you how to measure the correct dose of GRANIX. This dose will be measured in milliliters (mL). Step 1F: Wash your hands. When ready to inject, wash your hands well with soap and water, and dry with a clean towel. Step 2: Get ready Step 2A: Take the cap off the vial (Figure B). Clean the rubber stopper with 1 alcohol swab. Step 2B: Check the packaging for the syringe and needle . If the packaging has been open or damaged, do not use that syringe and needle. Throw away (dispose of) that syringe and needle in your sharps disposal container. Step 2C: Hold the syringe by the barrel with the needle cap pointing up. Carefully pull the needle cap straight off and away from your body (Figure C). Important: Throw away (Dispose of) the needle cap. Step 2D: Keep the vial on the flat work surface and insert the needle straight down through the rubber stopper on top of the vial. Do not insert the needle through the rubber stopper more than 1 time (Figure D). Step 2E: Push the plunger down and inject all the air from the syringe into the vial of GRANIX (Figure D) Step 2F: Keep the needle in the vial and turn the vial upside down. Make sure that the GRANIX liquid is covering the tip of the needle (Figure E). Step 2G: Keep the vial upside down and slowly pull back on the plunger to fill the syringe barrel with GRANIX to the correct marking amount (mL) of medicine that matches the dose your healthcare provider prescribed. Step 2H: Keep the needle in the vial and check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe barrel with your finger until the air bubbles rise to the top. Slowly push the plunger up to push the air bubbles out of the syringe (Figure F). Step 2I: Keep the tip of the needle in the liquid and pull the plunger back to the number on the syringe barrel that matches your dose. Check again for air bubbles. The air in the syringe will not hurt you, but too large an air bubble can reduce your dose of GRANIX. If there are still air bubbles, repeat the steps above to remove them. Step 2J: Check again to make sure that you have the correct dose in the syringe. It is important that you use the exact dose prescribed by your healthcare provider. Do not remove the needle from the vial. Lay the vial down on its side with the needle still in the vial while you prepare the injection site (Figure G). Step 3 – Select and prepare the injection site Step 3A: Choose an injection site (Figure H) You can use: - Stomach-area (abdomen): Except for a 2 -inch area around the navel (belly button) - Thighs: Top or middle area of thighs Thighs: Top or middle area of thighs - Arms: Fleshy areas on upper, back part of the arm (only if someone else is giving you the injection) Arms: Fleshy areas on upper, back part of the arm (only if someone else is giving you the injection) - Upper outer area of your buttocks: Fleshy areas around the back of the upper hips and upper sides of the buttocks (only if someone else if giving you the injection ). Upper outer area of your buttocks: Fleshy areas around the back of the upper hips and upper sides of the buttocks (only if someone else if giving you the injection ). - If 2 injections will be performed, then the second injection should be at least 1 inch away from the first injection. Choose Injection Site Figure H Do not inject into areas that are tender, red, bruised, hard, or have scars or stretch marks. Important: You should select a different injection site each time you give yourself an injection. If you want to use the same injection site for a dose requiring 2 injections, make sure the second injection site is at least 1 inch away from the first injection site. Step 3B: Clean the injection site using a new alcohol swab (Figure I). Allow site to dry for 5-10 seconds to avoid stinging. If giving 2 injections, then the distance between the 2 injection sites should be at least 1 inch apart. - Do not touch this area again before injecting. Do not touch this area again before injecting. Step 4 –Inject medication Step 4A: Remove the prepared syringe and needle from the vial. Step 4B: With your other hand, pinch the skin around the injection site to create a firm surface (Figure J). Important: Keep skin pinched while inserting the needle. Step 4C: Insert the needle at a 45 to 90 degree angle (Figure K) - Hold the body of the syringe between your thumb and index finger. Hold the body of the syringe between your thumb and index finger. - Use a quick motion to fully insert the needle straight into the pinched skin at a 45 to 90 degree angle. Use a quick motion to fully insert the needle straight into the pinched skin at a 45 to 90 degree angle. - When the needle is inserted, you can release the pinched skin. - Do not hold or push on the plunger while inserting the needle into the skin. Step 4D Push the plunger down to inject all of the GRANIX (Figure L) - Use your finger to gently push down on the plunger. Use your finger to gently push down on the plunger. - When the plunger head is as far down as it will go, all of the GRANIX has been injected. When done, gently remove the needle from the skin. When the plunger head is as far down as it will go, all of the GRANIX has been injected. When done, gently remove the needle from the skin. Step 4E: Throw away (d ispose of) used needle and syringe - Put your used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash. - If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal. - Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. Step 4F: Treat the injection site if needed and wash your hands. If you see drops of blood at the injection site, you can press a cotton ball or gauze over the injection site for several seconds to stop the bleeding. Apply bandage, if needed. When you are finished, wash your hands with soap and water (Figure M). Step 4G: Repeat steps 1E through 4F with a new vial of GRANIX if your healthcare provider instructs you that your dose is more than 1 vial. If you have any questions or concerns about your dose of GRANIX or how to prepare and give your injections, call your healthcare provider. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured by: UAB Teva Baltics Vilnius, Lithuania U.S. License No. 1803 Distributed by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Product of Israel Revised: 11/2023 TBOIFUV-003 ©2023 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd.

Product summary:

GRANIX solution for injection is supplied as a single-dose, preservative-free clear solution, in either a vial or, a prefilled syringe made from Type I glass which has a permanently attached stainless steel needle. The active substance is tbo-filgrastim. Prefilled Syringes (UltraSafe Passive® Needle Guard) GRANIX 300 mcg/0.5 mL: Each prefilled syringe contains 300 mcg of tbo-filgrastim in 0.5 mL solution with a blue plunger in: GRANIX 480 mcg/0.8 mL: Each prefilled syringe contains 480 mcg of tbo-filgrastim in 0.8 mL solution with a clear plunger in: Prefilled Syringes GRANIX 300 mcg/0.5 mL: Each prefilled syringe contains 300 mcg of tbo-filgrastim in 0.5 mL solution with a blue plunger in: GRANIX 480 mcg/0.8 mL: Each prefilled syringe contains 480 mcg of tbo-filgrastim in 0.8 mL solution with a clear plunger in: Vials GRANIX 300 mcg/mL: Each vial contains 300 mcg of tbo-filgrastim in 1 mL solution. GRANIX 480 mcg/1.6 mL (300 mcg/mL): Each vial contains 480 mcg of tbo-filgrastim in 1.6 mL solution. GRANIX and all its components are not made with natural rubber latex [see Dosage and Administration (2.2)] . Store GRANIX in a refrigerator at 36°F to 46°F (2°C to 8°C). Protect from light. Within its shelf life, the product may be removed from 36°F to 46°F (2°C to 8°C) storage for a single period of up to 5 days between 73°F to 81°F (23°C to 27°C). If not used within 5 days, the product may be returned to 36°F to 46°F (2°C to 8°C) up to the expiration date. Dispose of syringes if stored at room temperature for more than 5 days. Avoid shaking. The solution should be visually inspected prior to use. Only clear solutions without particles should be used. Exposure to 23°F to 30°F (-1°C to -5°C) for up to 72 hours and temperatures as low as 5°F to -13°F (-15°C to -25°C) for up to 24 hours do not adversely affect the stability of GRANIX. Single-dose syringe and single-dose vial – discard unused portion. Any unused product or waste material should be disposed of in accordance with local requirements. If GRANIX gets on the skin, wash the area with soap and water. If GRANIX gets in the eyes, thoroughly flush the exposed eye/eyes with water.

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GRANIX- tbo-filgrastim injection, solution

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