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RUCONEST- conestat alfa injection, powder, for solution
Santarus, Inc.
1 INDICATIONS AND USAGE
RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.
2 DOSAGE AND ADMINISTRATION
For intravenous use after reconstitution only.
2.1 Recommended Dosing
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Initiate treatment with RUCONEST under the supervision of a qualified healthcare professional experienced in the treatment of HAE.
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Appropriately trained patients may self-administer upon recognition of an HAE attack.
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The recommended dose of RUCONEST is 50 U per kg with a maximum of 4200 U to be administered as a slow intravenous injection over approximately 5 minutes.
If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Do not exceed 4200 U per dose. No more than two doses should be administered within a 24 hour period.
Table 1. Recommended dose of RUCONEST for an acute attack
Body Weight
RUCONEST Dose for Intravenous Injection
Volume (mL) of Reconstituted Solution (150 U/mL) to be Administered
< 84 kg
50 U per kg
Body weight in kg divided by 3
≥ 84 kg
4200 U (2 vials)
28 mL
2.2 Preparation and Handling
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Store RUCONEST in the original carton and protect from light prior to reconstitution.
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Do not use after expiration date on the product vial label.
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Water for Injection is not included in the RUCONEST package.
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Use aseptic technique to reconstitute, mix the solution, and to combine the reconstituted solution from more than one vial (see Reconstitution [2.3] and Administration [2.4]).
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Do not mix or administer RUCONEST with other medicinal products or solutions.
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Discard all partially used vials after treatment.
2.3 Reconstitution
Each package contains one single-use vial of RUCONEST. To reconstitute, the following are also required:
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Sterile Water for Injection (diluent) - At least 14 mL per vial of RUCONEST requiring reconstitution.
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Alcohol swab
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Syringe
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Commercially available vial adapter with vented vial spike and syringe luer lock or large bore needle. If using a syringe with vial adapter, use a new vial adapter for each vial of RUCONEST and diluent.
The procedures below are provided as general guidelines for the reconstitution and administration of RUCONEST.
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Ensure that the RUCONEST vial and diluent vial are at room temperature.
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Remove the flip caps from the RUCONEST and diluent vials. Treat the vial stoppers with the alcohol swab and allow to dry.
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Using the syringe/needle or syringe/vial adapter, withdraw 14 mL of sterile water for injection from the diluent vial.
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Remove the syringe and transfer the diluent to the RUCONEST vial. Add the diluent slowly to avoid forceful impact on the powder. Swirl the vial slowly to mix and avoid foaming.
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Repeat this procedure using another 14 mL of diluent and a second vial of RUCONEST.
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If the same patient is to receive more than one vial, the contents of multiple vials may be pooled into a single administration device (i.e., syringe).
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Inspect RUCONEST visually for particulate matter and discoloration after reconstitution and prior to administration. The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if the solution is cloudy, colored, or contains particulates.
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RUCONEST vial is for single-use only.
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Use the reconstituted product immediately, or within 8 hours stored at 2�C - 8�C (36�F - 46�F). Discard partially used vials.
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Do not freeze the reconstituted solution.
2.4 Administration
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Do not mix RUCONEST with other medicinal products. Administer RUCONEST by a separate infusion line.
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Use aseptic technique when administering RUCONEST.
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Follow recommended venipuncture guidelines for initiating intravenous therapy.
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Administer RUCONEST by slow intravenous injection over approximately 5 minutes.
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For self-administration, provide the patient with instructions and training for intravenous injection outside of a clinic setting so patients may self-administer RUCONEST upon recognition of symptoms of an HAE attack (see Patient Counseling Information [17]).
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After administration, immediately discard any unused product and all used disposable supplies in accordance with local requirements.
3 DOSAGE FORMS AND STRENGTHS
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RUCONEST is available as a lyophilized powder for reconstitution for injection in a single-use 25 mL glass vial. Each vial contains 2100 U of rhC1INH.
4 CONTRAINDICATIONS
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RUCONEST is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products.
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RUCONEST is contraindicated in patients with a history of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis.
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Severe hypersensitivity reactions may occur [see Patient Counseling Information (17)]. The signs and symptoms of hypersensitivity reactions may include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis during or after injection of RUCONEST. Should symptoms occur, discontinue RUCONEST and institute appropriate treatment. Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered.
5.2 Thromboembolic Events
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with risk factors. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Monitor patients with known risk factors for TE events during and after RUCONEST administration.
