Patient leaflet - Altuvoct 3000 IU powder and solvent for solution for injection
what it is used for
ALTUVOCT contains the active substa
nce efanesoctocog alfa, a replacement
factor VIII protein.
ALTUVOCT is used to treat and preven
t bleeding in patients 2 years and above
with severe or moderate haemophilia
A (the factor VIII blood level is 5% or
less).
Factor VIII is a protein naturally found i
n the body and is necessary for the blood
to form clots and stop bleeding. In pat
ients with haemophilia A, factor VIII is
missing or not working properly.
ALTUVOCT replaces the deficient or m
issing factor VIII. ALTUVOCT increases
factor VIII levels in the blood, helping
blood to form clots at the site of
bleeding which temporarily corrects t
he bleeding tendency.
- 2. What you need to know
before you use ALTUVOCT
Do not use ALTUVOCT
if you are allergic to efanesoctoco
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nu
There is a rare chance that you ma
including anaphylactic reaction (a ALTUVOCT. Signs of allergic reacti hives, tightness of the chest, diffic pressure. If any of these symptom and contact your doctor.
Talk to your doctor if you think tha
being controlled with the dose you reasons for this. Some people usin to factor VIII (also known as factor factor VIII inhibitors is a known co treatment with all factor VIII medi high levels, stop the treatment fro child will be monitored carefully f
Cardiovascular events
If you have heart disease or are at risk when using factor VIII medicines and t
Catheter-related complications If you require a central venous access complications including local infection catheter site thrombosis should be co
g alfa or any of the other ingredients of
rse before using ALTUVOCT.
y experience hypersensitivity reactions, severe, sudden allergic reaction) to ons may include generalised itching, ulty in breathing, and low blood s occur, stop the injection immediately
t your or your child’s bleeding is not receive, as there can be several g this medicine can develop antibodies VIII inhibitors). The formation of mplication that can occur during cines. These inhibitors, especially at m working properly and you or your or the development of these inhibitors.
for heart disease, take special care alk to your doctor.
device (CVAD), risk of CVAD-related s, presence of bacteria in the blood and nsidered.
Other medicines and ALTUVOC
Tell your doctor if you are using, have r medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, th planning to have a baby, ask your docto
Driving and using machines
ALTUVOCT has no or negligible influence
3. How to use ALTUVOCT
Treatment with ALTUVOCT will be starte care of patients with haemophilia A. ALT
After proper training in the correct inje may be able to administer ALTUVOCT a dose (in International Units or “IU”) for and whether it is used for prevention o
Always use this medicine exactly as yo doctor, pharmacist or nurse if you are
Keeping a record
Each time you use ALTUVOCT, record t the batch number.
Prevention of bleeding
The usual dose of ALTUVOCT is 50 inte
T
ecently used or might use any other ink that you may be pregnant or are r for advice before using this medicine.
on your ability to drive and use machines.
d by a doctor who is experienced in the UVOCT is given as an injection into a vein.
ction technique, patients or caregivers t home. Your doctor will calculate your you. This will depend on your weight r treatment of bleeding.
ur doctor has told you. Check with your not sure.
he date, the name of the medicine and rnational units (IU) per kg of body weight. The injection is given weekly.
Treatment of bleeding
The dose of ALTUVOCT is 50 internatio The dose and frequency may be adjust location of the bleeding.
Use in children and adolescent
ALTUVOCT can be used in children 2 yea is the same as in adults.
How ALTUVOCT is given
ALTUVOCT is given as an injection into ALTUVOCT’ for more information.
If you use more ALTUVOCT tha
Tell your doctor as soon as possible. Yo as your doctor has told you. Check wit you are not sure.
If you forget to use ALTUVOCT
Do not inject a double dose to make up as soon as you remember and then res you are not sure what to do, ask your d
If you stop using ALTUVOCT
If you stop using ALTUVOCT you may n or a current bleed may not stop. Do no to your doctor.
If you have any further questions on th
nal units (IU) per kg of body weight. ed depending on the severity and s
rs and above, the dose recommendation a vein. See ‘Instructions on how to use n you should
u should always use ALTUVOCT exactly h your doctor, pharmacist or nurse if for a forgotten dose. Inject your dose ume your normal dosing schedule. If octor, pharmacist, or nurse.
o longer be protected against bleeding t stop using ALTUVOCT without talking e use of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can ca
use side effects, although not
everybody gets them.
If hypersensitivity reactions, including
anaphylactic reaction occurs, the injection must be stopped immediately
, and you must contact your doctor right away.
Symptoms of hypersensitivity reaction
s/ anaphylactic reaction include:
- Swelling of the face
- rash
- generalised itching
- hives
- tightness of the chest
- difficulty breathing
burning and stinging at the
injection site
chills
- flushing
- headache
- low blood pressure
- general feeling of being unwell
- nausea
- restlessness and fast heartbeat
- feeling dizzy
- loss of consciousness
Risk of formation of inhibitors For children not previously treated wit
h factor VIII medicines, formation of inhibitor antibodies (see section 2) is v
ery common (may affect more than 1 in
10 patients); however, for patients wh
o have received previous treatment with factor VIII (more than 150 days of
treatment) the risk is uncommon
(may affect up to 1 in 100 patients). If
you or your child develop inhibitor antibodies, the medicine may stop wor
king properly and you or your child may experience persistent bleeding. If
this happens, you should contact your doctor immediately.
The following side effects may occur wi
Very common side effects (may
- headache
- arthralgia (joint pain)
Common side effects (may affe
- pain in extremity (arms, hands, legs
- back pain
- eczema (itchy, red or dry skin)
- rash
- urticaria (itchy rash)
- fever
- vomiting
Uncommon side effects (may a
- reactions at the injection site (inclu
Reporting of side effects
If you get any side effects, talk to your do any possible side effects not listed in this directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard Google Play or Apple App Store. By reporting side effects, you can help pr this medicine.
5. How to store ALTUVOCT
Keep this medicine out of the sight and
th this medicine.
affect more than 1 in 10 people)
ct up to 1 in 10 people)
or feet)
ffect up to 1 in 100 people)
ding bruising and inflammation)
ctor, pharmacist or nurse. This includes leaflet. You can also report side effects or search for MHRA Yellow Card in the ovide more information on the safety of reach of children.
Do not use this medicine after the expir and on the vial after ‘EXP’. The expiry da
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer carton in orde
Before ALTUVOCT powder is reconstitu temperature (≤ 30 °C) for a single perio that the product is removed from refrig carton. After storage at room temperat in the refrigerator.
Do not use beyond the expiry date print removing the carton from refrigeration,
Once you have dissolved the ALTUVOCT pre-filled syringe it should be used right solution.
After reconstitution the solution should opalescent. Do not use this medicine if visible particles.
Do not throw away any medicines via wa pharmacist how to throw away medicin will help protect the environment.
6. Contents of the pack and
What ALTUVOCT contains
The active substance is efanesoctoco
y date, which is stated on the carton te refers to the last day of that month.
r to protect from light.
ted it may be kept at room d no longer than 6 months. The date eration should be recorded on the ure, the product must not be put back ed on the vial or six months after whichever is earlier.
powder in the solvent provided in the away. Do not refrigerate the prepared be clear and colourless to slightly you notice that it is cloudy or contains stewater or household waste. Ask your es you no longer use. These measures other information g alfa (recombinant human coagulation factor VIII). Each vial of ALTUVOCT c 2 000, 3 000 or 4 000 IU efanesocto
- The other ingredients are sucrose, c arginine hydrochloride, polysorbate
What ALTUVOCT looks like and
ALTUVOCT is provided as a powder and The powder is a white to off-white pow preparation of the solution to inject, is After preparation, the solution to inject opalescent.
Each pack of ALTUVOCT contains 1 pow syringe, 1 plunger rod, 1 vial adapter, an
Marketing Authorisation Holder
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
Sweden
Manufacturer
Swedish Orphan Biovitrum AB (publ) Norra Stationsgatan 93
113 64 Stockholm
Sweden
This leaflet was last revised in 03/20
Turn the leaflet over for instruction for
ontains nominally 250, 500, 750, 1 000, cog alfa.
alcium chloride dihydrate, histidine,
80.
contents of the pack solvent for solution for injection. der or cake. The solvent provided for a clear, colourless solution.
is clear and colourless to slightly der vial, 3 mL solvent in pre-filled d 1 infusion set.
26.
preparation and administration.
EN
ALTUVOCT
Instructions on how
to use ALTUVOCT
READ THESE
INSTRUCTIONS
CAREFULLY BEFORE USING
ALTUVOCT
ALTUVOCT is administered
by intravenous injection
after dissolving the powder
for injection with the
solvent supplied in the
pre-filled syringe.
If your dose requires
multiple vials, you will be
provided with multiple
packs and ideally a large
syringe.
Your healthcare professional
should show you how to
prepare and inject
ALTUVOCT properly before
you use it for the first time.
Ask your healthcare
professional if you have any
question.
Important
Information
Check you have the correct product name and strength and are aware of the dosing frequency for ALTUVOCT. Do not use if the medicine has expired, has been opened or appears damaged.
ALTUVOCT should not be mixed with other solutions for injection.
ALTUVOCT should ideally be stored in the refrigerator. Allow the vial and solvent syringe to reach room temperature before use. Do not use external heat. Check all parts for damage before use, do not use if they appear damaged.
All parts are single use only. Wash your hands and clean a flat surface before kit preparation. Place syringe safely on a clean surface when not being handled.
Guide to parts (included in the carton) ALTUVOCT is reconstituted by dissolving the powder for injection (A) in the solvent supplied in the pre-filled syringe (B). ALTUVOCT solution should then be administered using the infusion set (E).
A. B. C.
Powder vial 3 mL syringe (pre-filled
with solvent)
Plunger rod
D. E.
Vial adaptor Infusion set
Additional parts (not included in the carton)
Ensure you have alcohol swabs (F) available.
Your pharmacist may have provided a separate large syringe (G) to draw up the solution from multiple vials into a single syringe. If a large syringe is NOT provided, follow steps 6 to 8 to administer the solution from each syringe.
F. G.
Alcohol swabs Large Syringe
- 1. Prepare the vial 2. Prepare the syringe 3. Attach syringe to vial a. Remove the vial
cap
b. Clean vial top c. Open vial adapter
package
d. Attach vial adapter a. Attach plunger rod b. Remove syringe
cap
a. Remove vial adapter package
b. Attach syringe to vial adapter
Hold the powder
vial (A) on a clean flat
surface and remove the
plastic cap.
Wipe the top of the vial with an alcohol swab. After cleaning, ensure nothing touches the
top of the vial.
Peel off the protective paper lid from the vial adapter package (D).
Do not touch the vial adapter, or remove it from its package.
Place the vial adapter
package squarely over
the top of the vial.
Press down firmly until
the adapter snaps into
place. The spike will
penetrate the vial
stopper.
Insert the plunger rod (C)
into the 3 mL syringe (B).
Turn the plunger rod
clockwise until it is
securely attached.
Snap off the top part of white 3 mL syringe cap at the perforations and set aside.
Do not touch the inside of cap or the syringe tip.
Lift the package away from the vial adapter and dispose.
Hold the vial adapter at the lower end. Place the syringe tip onto the top of the vial adapter. Turn the syringe clockwise to securely attach.
- 4.
Dissolve the powder and solvent 5. If using multiple vials 6. Draw solution into syringe a. Add solvent to vial b. Dissolve powder c. Inspect
solution
Inspect the solution before
administration. It should be clear and colourless.
Do not use the solution if cloudy or contains visible particles.
If your dose requires multiple vials, follow the steps below (5a and 5b) otherwise skip to step 6.
a. Draw back solution b. Detach syringe a. Repeat 1 to 4
Repeat steps 1 to 4 with all vials until you have prepared enough solution for your dose.
b. Using large syringe (G) provided by pharmacist
Slowly press the plunger
rod to inject all the solvent
into the vial.
With your thumb on the plunger rod, gently swirl the vial until powder is dissolved.
Do not shake.
Point the syringe up.
Slowly pull the plunger rod to draw all the solution into the syringe.
Detach the syringe from the vial by holding the vial adapter. Turn the syringe anticlockwise to detach.
Remove the 3 mL syringes from each vial (see step 6b), leaving the solution in each vial.
For each vial, attach the large syringe (G) to the vial adapter (see step 3b) and perform step 6, to combine the solution from each vial into the large syringe. In case you only need part of an entire vial, use the scale on the syringe to see how much solution you withdraw, as instructed by your healthcare professional.
- 7.
Prepare for injection 8. Inject solution 9. Dispose safely a. Remove tubing cap b. Attach syringe c. Prepare injection
site
d. Remove air from
syringe and tubing
a. Insert needle
Remove protective
needle cover.
Insert the needle into a
vein as instructed by
your doctor or nurse
and remove the
tourniquet if used.
You may use a
plaster to hold the
plastic wings of the
needle in place at the
injection site to
prevent movement.
b. Inject solution
The prepared solution should be injected intravenously over 1 to 10 minutes, based on your comfort level.
a. Remove needle b. Safe disposal
Safely dispose of the used needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container.
Do not reuse equipment.
Open infusion set (E)
packaging (do not use if
damaged).
Remove the tubing cap.
Do not touch the
exposed end of the
tubing set.
Attach prepared syringe to the end of the
infusion set tubing by turning the syringe
clockwise.
If needed apply
a tourniquet. Wipe injection site with an alcohol swab (F).
Remove air by pointing
the syringe up and
gently pressing the
plunger rod. Do not
push the solution
through the needle.
Injecting air into
the vein can be
dangerous.
Remove the needle.
Fold over the needle protector; it should snap into place.