CEPROTIN: Package Insert and Label Information (Page 3 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

CEPROTIN, Protein C Concentrate (Human), is supplied as a sterile, white or cream colored, lyophilized powder for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower than 240 mosmol/kg. One International Unit (IU) of protein C corresponds to the amidolytically measured activity of protein C in 1 mL of normal plasma. The potency (IU) is determined using a chromogenic substrate method referenced against the World Health Organization (WHO) International Standard (86/622).

CEPROTIN is available in single-dose vials that contain the following nominal product strengths:

Image: 500 IU per vial: (NDC: 0944-4177-05)
Image: 1000 IU per vial: (NDC: 0944-4179-10)

Actual potency is printed on the vial label.

One package of CEPROTIN contains one glass vial of CEPROTIN powder, one glass vial of Sterile Water for Injection, USP, one transfer needle, one filter needle, one full prescribing physician insert and one patient package insert.

CEPROTIN, packaged for sale, is stable for 3 years when stored refrigerated at 2°C–8°C (36°F-46°F). Do not freeze in order to prevent damage to the diluent vial. Store the vial in the original carton to protect it from light. The reconstituted solution should be used within 3 hours of reconstitution. Do not use beyond the expiration date on the CEPROTIN vial.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Inform patients of the following:

  • Early signs of hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The risk of an allergic type hypersensitivity reaction cannot be excluded [See WARNING AND PRECAUTIONS: Hypersensitivity (5.1)]. CEPROTIN may contain traces of mouse protein or heparin as a result of the manufacturing process. Allergic reactions to mouse protein or heparin cannot be ruled out. Immediately discontinue the injection/infusion and inform their physician as soon as possible if symptoms of hypersensitivity/allergic reaction occur.

Baxalta US Inc.
Lexington, MA 02421 USA
US License No. 2020

CEP367

BAXALTA® and CEPROTIN® are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

PATIENT INFORMATION

CEPROTIN [Protein C Concentrate (Human)]
Pronounced: see PRO ten

Please read this leaflet carefully before using CEPROTIN [Protein C Concentrate (Human)]. This leaflet is based on the information provided to your doctor and is a summary of the important information you need to know about your medicine for your severe congenital Protein C deficiency. This leaflet does not take the place of talking with your doctor and does not contain all of the information available about CEPROTIN.

Use this leaflet only after you have received instructions from your doctor. If you have any questions after reading this leaflet, ask your doctor or pharmacist.

1. What is CEPROTIN and what is it used for?

The name of your medicine is CEPROTIN, pronounced “see PRO ten”.

CEPROTIN contains Protein C, a natural protein that is made in the liver and is present in your blood. Protein C is a part of human plasma that regulates the blood clotting (coagulation) system and prevents abnormal clot formation (thrombosis). Plasma is the liquid part of human blood.

CEPROTIN is used to treat patients with Severe Congenital Protein C Deficiency for the prevention and treatment of:

  • venous thrombosis (blood clot in the vein), and
  • purpura fulminans (blood spots, bruising, and discoloring to skin as a result of clotting of small blood vessels in the skin).

2. How does CEPROTIN work?

CEPROTIN temporarily raises the levels of Protein C in the body. Protein C plays a major role in preventing your body from forming too many blood clots. CEPROTIN is for those patients who either don’t produce enough Protein C or whose Protein C doesn’t work correctly. CEPROTIN allows your body’s blood clotting process to function properly.

3. Who should not use CEPROTIN?

Do not use CEPROTIN unless your doctor confirms that you have severe congenital Protein C deficiency.

Tell your doctor about all your medical conditions.

Allergic to Mouse Protein or Heparin:

If you are known to have allergic-type reactions (rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and low blood pressure) to mouse protein or heparin, talk to your doctor before using this product. CEPROTIN contains small amounts of heparin and/or mouse protein as a result of the manufacturing process.

Low Sodium Diet/Kidney Impairment:

Talk with your doctor before using CEPROTIN if you are on a low sodium diet or have problems with your kidney, as the amount of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg.

Pregnancy or Breastfeeding:

Inform your doctor if you are pregnant or breastfeeding. Your doctor will decide if CEPROTIN may be used during pregnancy and/or breastfeeding.

Tell your doctor about all the medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. Tell your doctor if you are on a special diet.

4. What is the most important information I need to know about CEPROTIN?

You could have an allergic reaction to CEPROTIN. You should be aware of the early signs of allergic reactions. These include rash, hives, itching, tightness of the chest, difficulty breathing, throat tightness, and low blood pressure. The signs and symptoms of low blood pressure can include a weak pulse, feeling lightheaded or dizzy when you stand, and possibly shortness of breath. If you experience any of these symptoms while being treated with CEPROTIN, stop the treatment and contact your doctor. If you experience a severe allergic reaction, including difficulty breathing and (near) fainting, seek emergency treatment.

You could get an infectious disease since this drug product is made from human plasma. However, there are steps in collecting the plasma and in the making of CEPROTIN to lessen this possibility. For example, blood and plasma donors are screened for certain viral infections. There are also steps in the processing of the plasma that can inactivate or remove viruses.

5. What are the possible side effects of CEPROTIN?

Like all medicines, CEPROTIN can cause side effects, although not everyone gets them.

The common side effects to CEPROTIN observed in clinical trials were hypersensitivity or allergic reactions: lightheadedness itching, and rash.

There have also been individual reports, after the drug was marketed, of restlessness, increased sweating, and injection site reaction.

If you develop any side effects, including any not listed in this leaflet, please contact your doctor.

6. How do I use CEPROTIN?

CEPROTIN is given by intravenous administration (infusion into a vein). It is given to you under the close supervision of your doctor who is experienced in replacement therapy of coagulation factors/inhibitors and where monitoring of protein C activity is possible. Your dosage will vary depending upon your condition, your age, and your body weight. Your doctor may require that you have blood taken to help determine the dose of CEPROTIN that you should get. See the following Instructions for Use.

7. How do I store CEPROTIN?

Store CEPROTIN in powder form, without the diluent (Sterile Water for Injection) added. Store CEPROTIN in the refrigerator at 2°C to 8°C (36°F to 46°F). Store the vial in the original carton to protect it from light. Do not freeze to prevent damage to the diluent vial.

Do not use CEPROTIN beyond the expiration date printed on the CEPROTIN vial.

8. What are the ingredients in CEPROTIN?

Active ingredient: human Protein C

Other ingredients: human albumin, sodium chloride and trisodium citrate dihydrate

9. What does CEPROTIN look like?

CEPROTIN is a white or cream colored powder that is mixed with the water provided in the package (Sterile Water for Injection) before injection. After mixing with the Sterile Water for Injection, the solution is colorless to slightly yellowish and clear to slightly opalescent and free from visible particles.

10. What are the contents of the CEPROTIN package?

CEPROTIN comes in the following strengths:

Image: Approximate dosage strength of 500 IU per vial.
Image: Approximate dosage strength of 1000 IU per vial.

One package of CEPROTIN contains one vial of CEPROTIN powder, one vial of Sterile Water for Injection (diluent), one double-ended transfer needle, one filter needle, one full prescribing physician insert, and one patient package insert.

11. How can I contact Baxalta for more product information?

Baxalta Customer Service: 1-888-237-7684
Product website: www.ceprotin.com

CEP367

Revised: 8/2021

INSTRUCTIONS FOR USE

CEPROTIN [see-PRO-ten]
Protein C Concentrate (Human)
for intravenous use

This “Instructions for Use” contains information on how to inject CEPROTIN.

IMPORTANT: Contact your doctor if you experience any problems with this procedure. These instructions are intended only as an aid for those patients who have been instructed by their doctor on the proper way to self-infuse the product. Do not attempt to self-infuse unless you have been taught how by your doctor.

  1. Prepare a clean surface and gather all the materials you will need for the infusion. You will need to gather exam gloves (optional), alcohol swabs (or other suitable solution suggested by your doctor), a winged infusion set, and a tourniquet, as these are not provided with your package of CEPROTIN.
  2. Check the expiration date on the CEPROTIN vial. Do not use CEPROTIN after the expiration date.
  3. Let the vial of CEPROTIN and the vial of Sterile Water for Injection, USP (diluent) warm up to room temperature.
  4. Wash your hands and put on clean exam gloves (optional).
  5. Remove caps from the CEPROTIN and diluent vial to expose the centers of the rubber stoppers.
  6. Cleanse the stoppers with an alcohol swab (or other suitable solution suggested by your doctor) by rubbing the stoppers firmly for several seconds and allow them to dry.
  7. Remove the protective covering from one end of the double-ended transfer needle and insert the exposed needle through the center of the diluent vial stopper.
  8. While keeping the needle in the diluent vial, remove the protective covering from the other end of the double-ended transfer needle.
  9. Invert the diluent vial over the upright CEPROTIN vial. Then, insert the free end of the needle through the CEPROTIN vial stopper at its center. The vacuum in the vial will draw in the diluent. If there is no vacuum in the CEPROTIN vial, do not use the product. Contact Baxalta Customer Service.
  10. Separate the two vials by removing the needle from the diluent vial stopper. Then, remove the transfer needle from the CEPROTIN vial. Do not attempt to recap the needle and do not dispose it in ordinary household trash. Place the needle in a hard-walled Sharps container for proper disposal.
  11. Gently swirl the CEPROTIN vial until all the powder is completely dissolved. The solution should be colorless to slightly yellowish and free of visible particles. Do not use the solution if you see particles in it. Administer CEPROTIN at room temperature within 3 hours of mixing.
  12. Attach the filter needle to a disposable syringe and draw back the plunger to allow air into the syringe. Insert the filter needle into the reconstituted CEPROTIN.
  13. Inject air into the vial, and then withdraw the solution into the syringe.
  14. Remove and discard the filter needle from the syringe. Do not attempt to recap the needle and do not dispose it in ordinary household trash. Place the needle in a hard-walled Sharps container for proper disposal.
  15. Attach a winged infusion set, if available, or a suitable needle (not supplied) for the injection.
  16. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe.
  17. Apply a tourniquet, and prepare the injection site by wiping the skin well with an alcohol swab (or other suitable solution suggested by your doctor).
  18. Insert the needle into the vein, and remove the tourniquet. Infuse CEPROTIN. CEPROTIN should be administered at a maximum injection rate of 2 milliliters (mL) per minute except for children with a bodyweight of < 10 kg (22 pounds), where the injection rate should not exceed a rate of 0.2 mL per kilogram per minute.
  19. Remove the needle from the vein and apply pressure with sterile gauze to the infusion site for several minutes. Do not attempt to recap the needle after the infusion, and do not dispose it in ordinary household trash. Place the needle with the used syringe in a hard-walled Sharps container for proper disposal.
  20. Clean up any blood with a freshly prepared mixture of 1 part bleach and 9 parts water, soap, and water, or any household disinfecting solution.

BAXALTA® and CEPROTIN® are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

CEP367

Revised: 8/2021

Important: Contact your doctor if you have any questions or experience any adverse effects. These instructions are intended as an additional aid only for those patients who have been instructed by their doctor on the proper way to self-infuse CEPROTIN. If you have not been instructed to self-infuse by your doctor, do not attempt to self-infuse.

PRINCIPAL DISPLAY PANEL — Kit Carton — NDC 0944-4177-05

Protein C
Concentrate (Human)
CEPROTIN

Single-dose Vial

Lyophilized Powder for Solution for Injection

Shire

For Intravenous Administration Only.

See enclosed package insert for dosage and directions for use.
Store in refrigerator (2 – 8°C [36° – 46°F]).
Avoid freezing to prevent damage to the diluent bottle.
Protect from light.

During reconstitution, swirl vial gently until all material is
dissolved.

Administer within 3 hours after reconstitution.Do not refrigerate after reconstitution.

PRINCIPAL DISPLAY PANEL -- Kit Carton -- NDC 0944-4177-05
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Label — NDC 0944-4176-01

Shire

NDC 0944-4176-01

Protein C Concentrate (Human)
CEPROTIN

Single-dose Vial

Lyophilized Powder for Solution for Injection. For Intravenous Administration Only.

See package insert. Rx only.

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Label -- NDC 0944-4176-01
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Label — NDC 52919-003-08

5 mL

NDC 52919-003-08

Shire

Sterile Water for Injection, USP
for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substance has been
added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion. Rx Only

Single-Dose Container

Nonpyrogenic

PRINCIPAL DISPLAY PANEL -- 5 mL Vial Label -- NDC 52919-003-08
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Kit Carton — NDC 0944-4179-10

Protein C
Concentrate (Human)
CEPROTIN

Single-dose Vial

Lyophilized Powder for Solution for Injection

Shire

For Intravenous Administration Only.

See enclosed package insert for dosage and directions for use. Store in
refrigerator (2 – 8°C [36° – 46°F]). Avoid freezing to prevent damage to
the diluent bottle. Protect from light.

During reconstitution, swirl vial gently until all material is dissolved.

Administer within 3 hours after reconstitution. Do not refrigerate afterreconstitution.

PRINCIPAL DISPLAY PANEL -- Kit Carton -- NDC 0944-4179-10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label — NDC 0944-4178-02

Shire

NDC 0944-4178-02

Protein C Concentrate (Human)
CEPROTIN

Single-dose Vial

Lyophilized Powder for Solution for
Injection. For Intravenous Administration Only.

See package insert. Rx only.

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Label -- NDC 0944-4178-02
(click image for full-size original)

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