Storage, Stability and Handling
How should HyQvia be stored?
Hyqvia should be stored in a refrigerator between 2 and 8 degrees C
HyQvia is indicated as a replacement therapy for patients diagnosed with what?
Primary humoral Immunodeficiency and Secondary humoral Immunodeficiency
This was the most frequently reported adverse reaction reported in clinical trials.
Site reactions
What is the ONLY route of administration HyQvia is approved for?
Subcutaneous administration
How does HyQvia work?
HyQvia is used for patients who do not have enough antibodies in their blood or have weakened immune systems. Regular HyQvia infusions raise abnormally low immunoglobulin levels in the blood to normal levels (replacement therapy).
When Hyqvia is removed from the fridge it should be allowed to do this before use.
warm up to room temperature
Health Canada has NOT authorized an indication for use in these patients at this time.
1. Pediatric
2. Neuro
3. Fertility
There are over 15 common reactions observed in over 5% of patients during clinical trials. Name three common adverse reactions a patient may experience.
1. Nausea
2. Abdominal pain
3. Diarrhea
4. Vomiting
5. infusion site pain
6. Infusion site erythema (skin reaction)
7. Infusion site swelling
8. Infusion site pruritus (itchy/irritated skin)
9. Asthenic conditions (physical weakness or lack of energy)
10. Pyrexia (raised body temperature)
11. Edema (swelling due to fluid retention)
12. Myalgia (muscle aches/pains)
13. Arthralgia (Joint stiffness)
14. Back pain
15. Headache
16. Dizziness
17. Migraine
18. Rash
19. Hypertension
If a patient misses a dose with HyQvia when should they be instructed to resume scheduled treatments?
As soon as possible
HyQvia is supplied in a dual vial unit of two single use vials of what?
10% Ig and rHuPH20
HyQvia must be used within this number of months after removal from the fridge.
3 months
HyQvia was evaluated in THESE 7 subjects in the clinical trail. The available data are too limited to draw safety conclusions for these patients. These patients however are adults, and therefore are NOT off-label.
Geriatric
Severe hypersensitivity reactions may occur, even in patients who had tolerated pervious Ig treatments.
In the case of a hypersensitivity reaction during an infusion a patient should do what?
Discontinue the HyQvia infusion immediately and institute appropriate treatment.
HyQvia is a 10% Ig and comes in 5 vial sizes (25ml, 50ml, 100ml, 200ml, and 300ml)
How many grams of Ig are in each vial size?
25ml vial = 2.5g Ig
50ml vial = 5.0g Ig
100ml vial = 10.0g Ig
200ml vial = 20.0g Ig
300ml vial = 30.0g Ig
What is rHuPH20 and what does it do?
RhuPH20 (recombinant human hyaluronidase) is a protein that facilitates the dispersion and absorption of Ig
Patients should visually inspect both components of HyQvia for WHAT prior to administration?
particulate matter and/or discoloration
These events have been reported in association with immunoglobulin products. They include myocardial infraction, stroke, pulmonary embolism and deep vein thrombosis.
Thrombotic and thromboembolic
__
Thrombotic = when blood clots block blood vessels
Thromboembolic = when a piece of a blood clot becomes stock in a blood vessel and largely obstructs blood flow
Human immunoglobulins are produced from human plasma. Despite screening donors and donor donations using plasa tools and other effective manufacturing steps, there is always a possibility of THESE being transmitted when human blood or plasma are administered.
infective agents (ie viruses and other pathogens).
Ex. HIV, Hep. B., Hep. C., parvovirus
The recommended dose frequency for HyQvia is once every __ to __ weeks.
once every 3 to 4 weeks
Human Immunoglobulins are prepared from pooled plasma from no fewer than ____ blood donations
1000
The dont's: With regards to storage and handling, what shouldn't you do with HyQvia? Provide 3 answers.
Acceptable answers:
Do not shake
Do not use heating devices to warm up HyQvia to room temperature
Do not freeze
Do not expose UV light
Do not use a vented vial access device to remove rHuPH20
HyQvia is contraindicated (should not be used) for patients with a history of ____, patients with known hypersensitivity to ______ or any of the ingredients in the formulation
patients with a history of anaphylactic or severe system reactions to IgG or hypersensitivity to recombinant human hyaluronidase (rHuPH20)
The safety profile of HyQvia was evaluated in four clinic trials with 124 unique patients receiving 3,202 infusions combined.
How many serious adverse reactions occurred during the HyQvia clinical trials.
ZERO
There are ___ (# ie 1,2,3) components of HyQvia that must be infused sequentially.
What are they and in what order are they infused?
There are two components of HyQvia, the rHuPH20 and 10% Ig.
The RhuPH20 should be administered first. The full contents of RHuPH20 vial should be administered regardless of whether the full content of Ig is administered.
RhuPh20 is produced by genetically engineering CHO cells using recombinant DNA techniques. What are CHO cells?
Chinese Hamster Ovary cells