Raplixa

• The Medicines Company

Serious side effects have been reported with Raplixa. See the “Raplixa Precautions” section.

Common side effects of Raplixa include the following:

• surgical pain
• nausea
• constipation
• fever
• decreased blood pressure

This is not a complete list of Raplixa side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Raplixa, there are no specific foods that you must exclude from your diet when receiving this medication.

In the U.S.

• Evarrest
• Raplixa
• Tachosil

Available Dosage Forms:

• Sheet
• Powder
• Pad
• Sponge

Therapeutic Class: Fibrin Sealant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fibrinogen and thrombin human topical powder or patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fibrinogen and thrombin human topical powder or patch in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to human blood products, history of or
• Arterial bleeding, severe or brisk or
• Infection on any part of the body or at the application site—Should not be used in patients with these conditions.

This section provides information on the proper use of a number of products that contain fibrinogen and thrombin, human. It may not be specific to Raplixa. Please read with care.

A doctor or other trained health professional will give you this medicine. This medicine is applied only to your skin or incision during surgery.

This medicine may be used with a sponge or a spray applicator. It should not be given as an injection.

Raplixa is a fibrin sealant indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.

Raplixa is used in conjunction with an absorbable gelatin sponge (USP) and may be applied directly or using the RaplixaSpray device.

Raplixa is available as dry, ready-to-use powder containing 79 mg human fibrinogen and 699 international units human thrombin per gram of powder. Raplixa is supplied in single-use glass vials in three sizes: 0.5 gram, 1 gram, and 2 grams per vial.

Raplixa is a fibrin sealant comprised of human plasma-derived fibrinogen and thrombin that is designed to be used as an adjunct to surgical hemostasis. Each component is separately spray dried with trehalose followed by blending the two components to provide a ready-to-use, pre-mixed, sterile, dry powder that is filled in sterile medical grade glass vials. Raplixa is manufactured aseptically, resulting in a sterile product in a sterile vial. Raplixa does not contain any preservatives.

Except for fibrinogen and thrombin, the product contains the following components added during the manufacturing: trehalose – 824 mg/g, calcium chloride – 11 mg/g, and traces of the components from the formulations of fibrinogen and thrombin raw materials: human albumin, sodium chloride, sodium citrate, and L-Arginine hydrochloride.

Viral Clearance

All human plasma used in the manufacture of Raplixa is tested for the presence of current specific virus infections using FDA-licensed serological assays and nucleic acid testing (NAT) assays for HBV, HIV-1/2, and HCV and found to be non-reactive (negative). The manufacturing procedures for fibrinogen and thrombin include processing steps designed to reduce the risk of viral transmission, including pasteurization, precipitation and adsorption steps.

Validation studies for fibrinogen and thrombin manufacturing steps were conducted for their capacity to inactivate and/or remove viruses. These in vitro validation studies were conducted, using samples from manufacturing intermediates spiked with virus suspensions of known titers followed by further processing under conditions equivalent to those in the respective manufacturing steps. The cumulative virus reduction factors (expressed as log10) are shown in Table 3 for each virus tested.

• Advise patients to consult their physician if they experience chest pain, shortness of breath, difficulty speaking or swallowing, leg tenderness or swelling, or other symptoms of thromboembolism.
• Inform patients that Raplixa may carry a risk of transmitting infectious agents, (e.g., viruses such as hepatitis A and parvovirus B19 and theoretically the CJD agent). Instruct patients to consult their physician if symptoms of B19 virus infection (fever, drowsiness, and chills, followed two weeks later by a rash and joint pain) or hepatitis A (several days to weeks of poor appetite, fatigue and low-grade fever followed by nausea, vomiting and abdominal pain, dark urine, yellowed complexion) appear.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.
© 2016 Mallinckrodt.

Manufactured by Nova Laboratories, Ltd., Leicester, LE18 4YL, United Kingdom for ProFibrix BV and distributed by Mallinckrodt Hospital Products Inc., Hazelwood, MO 63042 USA

ProFibrix BV (Mallinckrodt Pharmaceuticals), Darwinweg 24, 2333 CR Leiden, The Netherlands

US License No. 1994

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