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HAEGARDA is a brand name for C1 Esterase Inhibitor, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: HAEGARDA (C1 Esterase Inhibitor Subcutaneous (Human)) is indicated for : Routine prevention of Hereditary Angioedema (HAE) attacks in adolescents and adult patients. 1.1 Pediatrics Pediatrics (>8 years): Clinical study has been performed in children >8 years of age (see section WARNINGS AND PRECAUTIONS, subsection…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Not applicable. 2 Recommended Dose and Dosage Adjustment The recommended dose of HAEGARDA is 60 IU/kg body weight twice weekly (every 3-4 days) administered after reconstitution by subcutaneous injection at a rate tolerated by the patient.
HAEGARDA is administered subcutaneously in the abdominal area or other subcutaneous injection sites. The maximum tolerated dose used in patients in clinical studies was 10,000 IU, corresponding to a volume of 20 mL, twice weekly by subcutaneous injection.
3 Reconstitution Subcutaneous HAEGARDA 2000 IU should be reconstituted with the provided 4 mL of Sterile Water for Injection (Diluent). 6 mL of Sterile Water for Injection (Diluent). 6 mL 500 IU/mL See section 11 STORAGE, STABILITY AND DISPOSAL for the recommended storage period and conditions.
4 Administration HAEGARDA is intended for self-administration by subcutaneous injection only. The patient or caregiver should be trained on how to administer HAEGARDA as needed. General Instructions: The reconstituted solution for HAEGARDA should be colourless and clear to slightly opalescent.
Reconstitution is generally achieved within 5 minutes but may take as long as 10 minutes. After filtering/withdrawal (see below) reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Do not use solutions that have particles or deposits in them. Reconstitution and withdrawal must be carried out using aseptic techniques. In the absence of compatibility studies HAEGARDA must not be mixed with other medicinal products and diluents.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The suggested infusion site for the injection of HAEGARDA is the abdominal area, however other subcutaneous injection areas can be used.
In the clinical trials, HAEGARDA was injected into a single site each administration and subsequent injection sites were rotated. The reconstituted preparation should be administered by subcutaneous injection at a rate tolerated by the patient.
If the reconstituted product is not administered immediately, storage shall not exceed 8 hours at room temperature. The reconstituted product should only be stored in the vial. Follow the steps below and use aseptic technique to reconstitute and administer HAEGARDA.
1 Adverse Reaction Overview Adverse reactions occurring in more than 4% of subjects treated with HAEGARDA were: injection site reaction, hypersensitivity, nasopharyngitis and dizziness. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug . Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Of the 90 subjects randomized in Study 3001 (see section CLINICAL TRIALS), 86 subjects received at least 1 dose of HAEGARDA and 86 subjects received at least 1 dose of placebo (Table 3). 3 weeks for HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human) Page 13 of 29 placebo).
Eligible patients were also able to participate in Study 3002 for up to 140 weeks (n=126, randomized, 110 completed the study at week 53, and around 45 subjects completed the Extension Period of 88 weeks). 2) N = number of subjects receiving the treatment; n = number of subjects experiencing ≥1 event.
* Includes subjects who were treated with 40 IU/kg or 60 IU/kg HAEGARDA. † Includes the MedDRA Preferred Terms: Injection site bruising, Injection site coldness, Injection site discharge, Injection site erythema, Injection site hematoma, Injection site hemorrhage, Injection site induration, Injection site edema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction, Injection site scar, Injection site swelling, Injection site urticaria, Injection site warmth.
‡ Includes the MedDRA Preferred Terms: Hypersensitivity, Pruritus, Rash, and Urticaria. 5% resolved within 1 day after onset. Overall, safety data from Study 3002, consisting of 64 roll-over patients from Study 3001 and 62 non-rollover patients, was consistent with the safety data from Study 3001.
This product is prepared from large pools of human plasma. Thus, there is a possibility it may contain causative agents of viral or other undetermined diseases General HAEGARDA should not be used to treat an acute HAE attack. In case of an acute HAE attack, individualized treatment should be initiated.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. Products made from human plasma may contain infectious agents such as viruses and, theoretically, the agent responsible for the Creutzfeldt-Jakob disease (CJD).
This also applies to unknown or emerging viruses and other pathogens. HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human) Page 11 of 29 The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and for the non - enveloped viruses HAV and parvovirus B19.
Appropriate vaccination (hepatitis A and B) should be generally considered for patients in regular/repeated receipt of human plasma-derived products. It is strongly recommended that every time HAEGARDA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health professional to CSL Behring at 1-866-773-7721. The physician should discuss the risks and benefits of this product with the patient.
HAEGARDA (C1 Esterase Inhibitor Subcutaneous (Human)) is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1 Esterase Inhibitor (C1-INH) preparations or to any ingredient in the formulation or component of the container.
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of C1 Esterase Inhibitor in Canada.
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Use the Mix2Vial® filter transfer set, syringe and either the SC infusion set or the hypodermic needle provided with HAEGARDA (see section DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).
Step 1:
Assemble supplies HAEGARDA and diluent vials (Ensure that the HAEGARDA and the diluent are at room temperature) Mix2Vial® SC infusion set or hypodermic needle HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human) Page 6 of 29 Sterile syringe Alcohol or disinfectant wipes Step 2: Clean surface Thoroughly clean a table or other flat surface using alcohol or disinfectant wipes.
Step 3:
Wash hands Thoroughly wash and dry your hands.
Reconstitution:
Step 4: Clean Stoppers Remove the flip caps from both vials (HAEGARDA and diluent). Wipe rubber stoppers with an antiseptic wipe and allow the rubber stopper to dry.
Step 5:
Open the Mix2Vial® package by peeling off the lid. Do not remove the Mix2Vial® from the blister package!
Step 6:
Place the diluent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial® together with the blister package and push the spike of the blue adapter end straight down through the diluent vial stopper.
Step 7:
Carefully remove the blister package from the Mix2Vial® set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial® set.
Step 8:
Place the HAEGARDA vial on an even and firm surface. Invert the diluent vial with the Mix2Vial® set attached and push the spike of the transparent adapter end straight down through the HAEGARDA vial stopper. The diluent will automatically flow into the HAEGARDA vial.
HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human) Page 7 of 29 Step 9:
With the diluent and HAEGARDA vial still attached to the Mix2Vial® transfer set, gently swirl the HAEGARDA vial to ensure that the powder is fully dissolved. ) Do not shake the vial.
Step 10:
With one hand grasp the HAEGARDA-side of the Mix2Vial® set and with the other hand grasp the diluent-side and unscrew the set carefully counter-clockwise into two pieces. Discard the diluent vial with the blue Mix2Vial® adapter attached.
Step 11:
Draw air into an empty, sterile syringe. While the HAEGARDA vial is upright, connect the syringe to the Mix2Vial®'s Luer Lock fitting by screwing clockwise. Inject air into the HAEGARDA vial.
Step 12:
While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human) Page 8 of 29 Step 13:
Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial® adapter from the syringe by unscrewing counter-clockwise.
The reconstituted solution should be colorless, clear and free from visible particles. Do not use if particulate matter or discoloration is observed.
Administration:
Step 14: Prepare injection site Select an area on the abdomen (stomach; Figure 1) or another subcutaneous area for the injection as discussed with a health professional. Use a different place from last injection. New injection sites should be at least 5 centimeters (2 […]
1 Clinical Trial Adverse Reactions – Pediatrics Not applicable. 3 Less Common Clinical Trial Adverse Reactions Not applicable. 1 Less Common Clinical Trial Adverse Reactions – Pediatrics Not applicable. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Not applicable.
5 Post-Market Adverse Reactions Not applicable.
Cardiovascular Thrombosis has occurred in treatment attempts with high doses of C1 -INH intravenous (IV) for prophylaxis or therapy of capillary leak syndrome before, during or after cardiac surgery under extracorporeal circulation (unlicensed indication and dose).
At the recommended SC doses, a causal relationship between TEEs and the use of C1-INH concentrate has not been established. Driving and Operating Machinery HAEGARDA has no or negligible influence on the ability to drive and use machines.
g. discontinue injection) and appropriate medical care must be initiated. 1 Pregnant Women There are limited data that suggest no increased risk from the use of general C1-INH products in pregnant women. C1-INH is a physiological component of human plasma.
No studies on reproduction and developmental toxicity have been performed with HAEGARDA in animals. No adverse effects on fertility, pre- and postnatal development are expected in humans. In a retrospective case collection study, 22 pregnant women with type I HAE and ranging in age from 20 to 38 years received C1-INH doses of 500 or 1000 IU per intravenous (IV) administration for the treatment of acute attacks before, during, and/or after pregnancy (total of 35 pregnancies).
No adverse events were associated with C1-INH treatment before, during, or after pregnancy2. In an observational registry (overall 318 subjects) data were collected o n 11 pregnancies in 10 subjects (16 to 40 years old) receiving up to 3000 IU C1-INH (IV administration) to treat or prevent HAE attacks.
No adverse events were associated with C1-INH treatment3. 2 Martinez Saguer I, Rusicke E, Aygören Pürsün E, Heller C, Klingebiel T, Kreuz W. Characterization of acute hereditary angioedema attacks during pregnancy and breast-feeding and their treatment with C1 inhibitor concentrate.
Am J Obstet Gynecol. e1-7 3 Fox J, Vegh AB, Martinez-Saguer I, Wuillemin WA, Edelman J, Williams-Herman D, Rojavin M, Rosenberg T. Safety of a C1- inhibitor concentrate in pregnant women with hereditary angioedema. Allergy Asthma Proc.
2017 May 1;38(3):216 -221. HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human) Page 12 of 29 In an open-label extension study (Study 3002), 4 pregnant women with type I HAE and ranging in age from 19 to 32 years received C1-INH (subcutaneous (SC) administration).
Patients received 40 or 60 IU/kg per SC administration for 4-8 weeks (9-15 doses) during the first trimester. All four women delivered healthy babies. 2 Breast-feeding There is no information regarding the excretion of HAEGARDA in human milk, the effect on the breastfed infant, or the effects on milk production.
It is unknown whether C1-INH is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HAEGARDA and any potential adverse effects on the breastfed infant from HAEGARDA or from the underlying maternal condition.
HAEGARDA should be given to a nursing mother only if clearly needed. 8 months (ranging from 1 to 34 months). Mothers were treated postpartum with C1-INH doses up to 1000 IU per IV administration for the treatment of acute HAE attacks.
No adverse events to the mothers were associated with C1 -INH treatment after pregnancy. No information regarding the effect on the breastfed infant was reported. 3 Pediatrics Pediatrics (<18 years): The safety and effectiveness of HAEGARDA were evaluated in a subgroup of eleven pediatric patients 8 to <17 years of age in both a randomized, double blind, placebo controlled, crossover, routine prophylaxis trial (Study 3001) and Study 3002.
Results of subgroup analysis by age were consistent with overall study results ( see section CLINICAL TRIALS). […]