- if you are allergic to pegcetacoplan or any of the other ingredients of this medicine (listed in section 6).
- if you have an infection caused by so-called encapsulated bacteria.
- if you are not vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae.
Talk to your doctor, pharmacist or nurse before using ASPAVELI.
Before starting ASPAVELI, inform your doctor if you have any infections.
Because the medicine targets the complement system, which is part of the body’s defences against infection, the use of this medicine increases your risk of infections, including those caused by the so-called encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae. These are severe infections affecting your nose, throat and lungs or the linings of the brain and can spread throughout the blood and body.
Talk to your doctor before you start ASPAVELI to be sure that you receive vaccination against Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae if you have not had these vaccines in the past. If you have had these vaccines in the past, you might still need additional vaccinations before starting this medicine. These vaccinations should be given at least 2 weeks before beginning therapy. If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection for 2 weeks after you have been vaccinated. Following vaccination, you may be more closely monitored by your doctor for symptoms of infection.
Infection symptoms
If you experience any of the following symptoms, you should immediately inform your doctor:
- headache and a fever
- fever and a rash
- fever with or without shivers or chills
- shortness of breath
- high heart rate
- clammy skin
- headache with a stiff neck or stiff back
- headache with nausea (feeling sick) or vomiting
- eyes sensitive to light
- muscle aches with flu-like symptoms
- confusion
- extreme pain or discomfort
Make sure that you keep your vaccinations up to date. You should also be aware that vaccines reduce the risk of serious infections, but do not prevent all serious infections. In accordance with national recommendations, your doctor might consider that you need supplementary measures such as antibacterial medicines to prevent infection.
Allergic reactions may appear in some patients. In case of severe allergic reaction, discontinue ASPAVELI infusion and seek medical help immediately. Severe allergic reaction may present as difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing or collapse.
Injection site reactions have been observed with the use of ASPAVELI. You should undergo appropriate training in proper injection technique before self-administering.
During your treatment with ASPAVELI your doctor will perform regular check-ups, including blood tests for lactate dehydrogenase (LDH) levels and tests of renal function, and may adjust your dose if needed.
Use of silica reagents in coagulation tests should be avoided as it can result in artificially prolonged activated partial thromboplastin time (aPTT).
Do not give this medicine to children with PNH under 18 years of age because it has not been studied in this age group.
Do not give this medicine to children with C3G or primary IC-MPGN under 12 years of age because it has not been studied in this age group.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Women of childbearing potential
The effects of the medicine on an unborn child are not known. The use of effective contraception methods is recommended during treatment and up to 8 weeks after treatment by women who are able to get pregnant. Ask your doctor for advice before taking this medicine.
Pregnancy/breast-feeding
ASPAVELI is not recommended during pregnancy and breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
This medicine has no or negligible influence on the ability to drive and use machines.
Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
At least 2 weeks before you start treatment with this medicine, your doctor will review your medical records and may give you one or more vaccinations. If you cannot be vaccinated at least 2 weeks before you start treatment with ASPAVELI, to reduce the risk of infection, your doctor will prescribe antibiotics for 2 weeks after you have been vaccinated.
If you use this medicine to treat PNH
Dose for adults:
The initial recommended dose for adults with PNH is 1080 mg twice a week. You should take the twice weekly dose on Day 1 and Day 4 of each treatment week. If you are switching to ASPAVELI from another type of PNH medicine, called a C5 inhibitor, you should take ASPAVELI in addition to your current dose of C5 inhibitor as prescribed for 4 weeks. After 4 weeks you should stop taking your C5 inhibitor.
The dose or dosing interval should not be changed without consulting your doctor. Your doctor may adjust your dose to 1080 mg every third day (e.g., Day 1, Day 4, Day 7, Day 10, Day 13, and so forth) if appropriate. If you think you have missed a dose, speak to your doctor as soon as possible.
If you use this medicine to treat C3G or primary IC-MPGN
Dose for adults:
The initial recommended dose for adults with C3G or primary IC-MPGN is 1080 mg twice a week. You should take the twice weekly dose on Day 1 and Day 4 of each treatment week.
Dose for adolescents:
The initial recommended twice a week dose for adolescents with C3G or primary IC-MPGN is based on the patient´s body weight. Your doctor will calculate your dose based on the below dosing table. You should take the twice weekly dose on Day 1 and Day 4 of each treatment week.
Dosing table by body weight showing first dose, second dose, and maintenance dose infusion volumes. For 50 kg and above, 1080 mg twice weekly (20 mL) for all doses. For 35 to less than 50 kg, first dose 648 mg (12 mL), second dose 810 mg (15 mL), maintenance dose 810 mg twice weekly (15 mL). For 30 to less than 35 kg, first dose 540 mg (10 mL), second dose 540 mg (10 mL), maintenance dose 648 mg twice weekly (12 mL).
ASPAVELI is intended to be given as an infusion under the skin using:
- an infusion pump or
- an on-body delivery system.
Your first doses of the medicine will be given to you by healthcare professionals in a clinic or treatment centre. If treatment goes well, your doctor may discuss with you the possibility of you giving the medicine yourself at home. If this is appropriate, a healthcare professional will train you or a caregiver how to give the infusion.
Using the infusion pump, the infusion time is approximately 30 minutes if you use 2 infusion sites or approximately 60 minutes if using 1 site.
Using the on-body delivery system, the infusion time typically ranges from 30 to 60 minutes (depending on how quickly the medicine flows into your body).
The infusion should be started promptly after drawing this medicinal product into the syringe and completed within 2 hours after preparing the syringe.
Step 1 Prepare for infusion
Before you start:
1. Remove a single vial carton from the refrigerator. Keep the vial in the carton at room temperature and allow it to warm up for approximately 30 minutes. Do not try to speed up the warming process using a microwave or any other heat source.
2. Find a well-lit, flat work surface area, like a table.
3. Gather your supplies:
i) When using an infusion pump (Figure 1):
A. Syringe system infusion pump and manufacturer’s instructions (not shown)
B. Compatible syringe
C1. Transfer needle OR
C2. Needleless transfer device to draw up product from the vial
D. Infusion set (not shown; varies according to device manufacturer’s instructions)
E. Infusion tubing and Y-connector (if required)
F. Sharps container
G. Alcohol wipes
H. Gauze and tape, or transparent dressing
OR
ii) When using an on-body delivery system (Figure 2):
A. On-body delivery system and manufacturer´s instructions (not shown)
B. Compatible syringe
C1. Transfer needle OR
C2. Needleless transfer device to draw up product from the vial
F. Sharps container
G. Alcohol wipes
Thoroughly clean your work surface using an alcohol wipe.
Wash your hands thoroughly with soap and water. Dry your hands.
Step 2 Check the vial and liquid
Remove the vial from the carton. Carefully look at the liquid in the vial. ASPAVELI is a clear, colourless to slightly yellowish liquid. Check for particles or colour changes (Figure 3).
Do not use the vial if:
- The liquid looks cloudy, contains particles, or is dark yellow.
- The protective flip cap is missing or damaged.
- The expiry date (EXP) on the label has passed.
Step 3 Prepare and fill syringe
Remove the protective flip cap from the vial to expose the central portion of the grey rubber stopper of the vial (Figure 4). Throw the cap away.
Clean the stopper with a new alcohol wipe and allow the stopper to dry.
Option 1: If using a needleless transfer device (such as a vial adapter), follow the instructions provided by the device manufacturer.
OR
Option 2: If using a transfer needle and a syringe, follow the instructions below:
A. Attach a sterile transfer needle to a sterile syringe.
B. Pull back the plunger to fill the syringe with air, which should be about 20 mL (Figure 5).
C. Make sure the vial is in upright position. Do NOT turn the vial upside down. Push the air-filled syringe with the transfer needle attached through the centre of the vial stopper.
D. The tip of the transfer needle should not be in the solution to avoid creating bubbles. (Figure 6).
E. Gently push the air from the syringe into the vial. This will inject the air from the syringe into the vial.
F. Turn the vial upside down (Figure 7).
G. With the transfer needle tip in the solution slowly pull the plunger to fill the syringe with the prescribed dose of ASPAVELI (Figure 8).
H. Double check that you have withdrawn your prescribed dose. Any excess volume should be disposed.
I. Remove the filled syringe and the transfer needle from the vial.
J. Do not recap the transfer needle. Unscrew the needle and throw it away in the sharps container.
For infusion of the product using an on-body delivery system, follow the device manufacturer’s instructions. Throw away all used disposable supplies as well as any unused product and the empty vial as recommended by your healthcare professional.
For infusion of the product using a syringe system infusion pump, follow the steps below.
Step 4 Prepare syringe system infusion pump and tubing
Gather the infusion pump supplies and follow the device manufacturer’s instructions to prepare the pump and tubing.
Step 5 Prepare the infusion site(s)
A. Select an area on your abdomen (except for the five centimetres area around the belly button), thighs, hips, or upper arms region for the infusion(s) (Figure 9).
B. Use a different site(s) from the one you used for your last infusion. If there are multiple infusion sites, they should be at least 7.5 cm apart. Rotate infusion sites in between each infusion (Figure 10).
C. Avoid the following infusion areas:
a. Do not infuse into areas where the skin is tender, bruised, red, or hard.
b. Avoid tattoos, scars, or stretch marks.
D. Clean the skin at each infusion site(s) with a new alcohol wipe, starting at the centre and working outward in a circular motion (Figure 11).
E. Let the skin dry.
Step 6 Insert and secure the infusion needle(s)
A. Pinch the skin between your thumb and forefinger around the infusion site (where you intend to place the needle). Insert the needle into the skin (Figure 12). Follow the device manufacturer’s instructions on the angle of the needle.
B. Secure the needle(s) using sterile gauze and tape or a transparent dressing placed over the infusion site(s) (Figure 13).
Step 7 Start infusion
Follow the device manufacturer’s instructions to start the infusion.
Start the infusion promptly after drawing the solution into the syringe.
Step 8 Complete infusion
Follow the device manufacturer’s instructions to complete the infusion.
Step 9 Record infusion
Record your treatment as directed by your healthcare professional.
Step 10 Clean up
A. After the infusion is complete, remove the dressing and slowly take out the needle(s). Cover the infusion site with a new dressing.
B. Disconnect the infusion set from the pump and discard into the sharps container (Figure 14).
C. Throw away all used disposable supplies as well as any unused product and the empty vial as recommended by your healthcare professional.
D. Clean and store the syringe system infusion pump according to the device manufacturer’s instructions.
If you miss a dose, it should be taken as soon as possible; then take the next dose at the regularly planned time.
PNH is a lifelong condition and so it is expected that you will use this medicine for a long time. If you wish to stop using the medicine, please speak to your doctor first. If you stop taking the medicine suddenly, you may be at risk of making your symptoms worse.
If your doctor decides to stop your treatment with this medicine, follow their instructions for how to stop. Your doctor will monitor you closely for at least 8 weeks after stopping treatment for any signs of the destruction of red blood cells (haemolysis) due to PNH. Symptoms or problems that can happen due to destruction of red blood cell include:
- tiredness
- shortness of breath
- blood in the urine
- stomach-area (abdomen) pain
- drop in the number of your red blood cell count
- blood clots (thrombosis)
- trouble swallowing
- erectile dysfunction in males
If you have any of these signs and symptoms, contact your doctor.
C3G and primary IC-MPGN are lifelong conditions and so it is expected that you will use this medicine for a long time. If you wish to stop using the medicine, please speak to your doctor first.
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