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Kamrab
Sponsor
Device/Product name
Kamrab
Active Ingredient
Rabies immunoglobin
Date of decision
Published
Submission type
New biological entity
ATC codes
J06BB05
Decision
Approved
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Kamrab was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 June 2020 |
| First round evaluation completed | 30 November 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 25 February 2021 |
| Second round evaluation completed | 31 March 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 9 July 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 11 August 2021 |
| Completion of administrative activities and registration on ARTG | 16 August 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 181 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Solution for injection
Strength
150 IU/mL (corresponding with 300 IU/2 mL or 1500 IU/10 mL)
Other ingredients
Glycine, water (for injection) and sodium hydroxide (for pH adjustment)
Containers
Vial
Pack sizes
One (2 mL or 10 mL vial)
Routes of administration
Wound infiltration and intramuscular
Dosage
Post-exposure prophylaxis consists of a single dose of Kamrab and a full course of rabies vaccine. The recommended dose of Kamrab is 20 IU/kg body weight, given at the time of the first vaccine dose. Kamrab and the first dose of rabies vaccine should be given as soon as possible after exposure, and regardless of the time interval between exposure and initiation of post-exposure prophylaxis, as delays are potentially lethal. However, should a delay occur, Kamrab should be administered at any time up to and including seven days after the first dose of vaccine. The rabies vaccine should be given according to the manufacturer’s instructions
For further information refer to the Product Information.
Pregnancy category
B2Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
Kamrab (rabies immunoglobulin) was approved for the following therapeutic use:
Kamrab is rabies immunoglobulin indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. Kamrab should be administered concurrently with a full course of rabies vaccine.
- Do not administer additional (repeat) doses of Kamrab once vaccine treatment has been initiated, since this may interfere with the immune response to the rabies vaccine.
- Do not administer Kamrab to patients with a history of a complete pre-exposure or postexposure vaccination regimen and confirmed adequate rabies antibody titre.
What is this medicine and how does it work
Rabies is a zoonotic disease caused by ribonucleic acid (RNA) viruses in the family Rhabdoviridae, genus Lyssavirus. Virus is typically present in the saliva of rabid mammals and is transmitted primarily through a bite. Kamrab is infiltrated into the inoculation site (that is at the beginning of anti-rabies postexposure prophylaxis(PEP)) to previously unvaccinated persons, to provide immediate passive rabies virus neutralising antibody protection until the patient’s immune system responds to vaccination by actively producing antibodies.A protective threshold for rabies virus neutralising antibodies (RVNA) has never been established. However, the World Health Organization has generally accepted a RVNA of at least 0.5 IU/mL measured 14 days after initiation of PEP as protective. By comparison, the Advisory Committee on Immunisation Practices at the Centers for Disease Control recommends complete neutralisation of rabies virus at a 1:5 serum dilution by a rapid fluorescent focus inhibition test (RFFIT) from one to two weeks after prophylaxis; this corresponds to RVNA about 0.1 to 0.2 IU/mL. In support of these recommendations, there has been almost no documented clinical disease when the current rabies PEP regimen is administered appropriately.
What post-market commitments will the sponsor undertake
- Kamrab (rabies immunoglobulin) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicine Information (CMI) for Kamrab must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
The Kamrab Canadian-risk management plan (RMP) (version 1.0 (date not provided; data lock point October 2017), with Australia Specific annex (ASA) (version 0.2, January 2021), included with submission PM-2020-02488-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
The sponsor should provide a global or core RMP with an ASA, or an Australia-specific RMP to replace the Canadian-RMP, within 3 months of approval of this product. If an European Union (EU)-RMP become available within the next 3 months, the EU-RMP and an ASA should be provided.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- Laboratory testing & compliance with Certified Product Details
- All batches of Kamrab rabies immunoglobulin supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- When requested by the TGA, the Sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
- For all injectable products the Product Information must be included with the product as a package insert.