Package leaflet: Information for the user

CRYSVITA 10 mg solution for injection, 20 mg solution for injection, 30 mg solution for injection

burosumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

What CRYSVITA is and what it is used for
What you need to know before using CRYSVITA
How to use CRYSVITA
Possible side effects
How to store CRYSVITA
Contents of the pack and other information

1. What CRYSVITA is and what it is used for

What CRYSVITA is
CRYSVITA contains the active substance burosumab, a type of medicine known as a human monoclonal antibody.

What CRYSVITA is used for
CRYSVITA is used to treat X-linked hypophosphatemia (XLH). It is used in children and adolescents aged 1 to 17 years and in adults.
CRYSVITA is used to treat tumour-induced osteomalacia (TIO), also known as oncogenic osteomalacia, in cases where the tumour causing this condition cannot be successfully removed or located, in children and adolescents aged 1 to 17 years and in adults.

What is X-linked hypophosphatemia (XLH)?
X-linked hypophosphatemia (XLH) is a genetic disease.

People with XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
FGF23 reduces the amount of phosphate in the blood.
Low phosphate levels can cause:
- inadequate bone hardening and, in children and adolescents, inadequate bone growth
- pain and stiffness in the bones and joints

What is tumour-induced osteomalacia (TIO)?

People with TIO have higher levels of a hormone called FGF23, which is produced by certain types of tumour.
FGF23 reduces the amount of phosphate in the blood.
Low phosphate levels can cause softening of the bones, muscle weakness, fatigue, bone pain, and fractures.

How CRYSVITA works
CRYSVITA binds to FGF23 in the blood, blocking the action of this hormone and increasing the amount of phosphate in the blood, thereby helping to achieve normal levels.

2. What you should know before using CRYSVITA

Do not use CRYSVITA

if you are allergic to burosumab or to any of the other ingredients of this medicine (listed in section 6)
if you are taking phosphate supplements or certain vitamin D supplements (containing so-called active vitamin D, e.g. calcitriol)
if you already have high levels of phosphate in your blood ("hyperphosphatemia")
if you have severe kidney disease or renal failure.

Allergic reactions
Stop taking CRYSVITA and contact your doctor immediately if any of the following side effects occur, as they may be signs of an allergic reaction:

rash and itching all over the body
severe swelling of the eyelids, mouth or lips (angioedema)
shortness of breath
rapid heartbeat
sweating.

If you fall into any of the categories listed above, do not take CRYSVITA. If in doubt, consult your doctor before using CRYSVITA.
Warnings and precautions
Skin reactions
Skin reactions may occur at the injection site; see section 4 for further information. If these reactions are severe, inform your doctor.
Tests and monitoring
Your doctor will monitor levels of phosphate and calcium in your blood and urine and may perform a kidney ultrasound before and during treatment to reduce the risk of hyperphosphatemia (excess phosphate in the blood), hypercalcemia (excess calcium in the blood), and ectopic mineralization (calcium buildup in tissues such as the kidneys). Your serum parathyroid hormone level will also be monitored before and during treatment to reduce the risk of hyperparathyroidism (excess parathyroid hormone in the blood).
Children under 1 year of age
CRYSVITA must not be given to children under 1 year of age, as the safety and effects of the medicine have not been studied in this age group.
Treatment notes
If you self-administer the medicine or administer it to your child, you should record the following information: date of administration, name of the medicine, and batch number (shown on the packaging after "Lotto"). Keep these records in a safe place. If you have any doubts, consult your doctor, nurse, or pharmacist.
Other medicines and CRYSVITA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take CRYSVITA and inform your doctor if you are taking:

phosphate supplements
certain vitamin D supplements (containing so-called active vitamin D, e.g. calcitriol). There are some vitamin D supplements that you may continue or start using; your doctor will advise you which ones.

Consult your doctor before taking CRYSVITA:

if you are taking medicines that act like calcium in the body ("calcimimetics"). Your doctor may monitor your calcium levels more closely.
if you have TIO and are about to receive treatment for the underlying tumour (radiation therapy or surgical removal). In this case, treatment with CRYSVITA will only begin after treatment of the underlying tumour and if serum phosphate levels are low.
if you have problems related to the parathyroid glands.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine, as the effects of CRYSVITA on the baby are unknown.
CRYSVITA is not recommended during pregnancy.
If you are of childbearing potential, you must use an effective method of contraception (birth control) during treatment with CRYSVITA and for at least 14 weeks after your last dose. Discuss this with your doctor.
It is known that monoclonal antibodies such as CRYSVITA pass into breast milk during the first few days after birth, but after this initial period CRYSVITA may be used. Talk to your doctor about using CRYSVITA while breastfeeding so they can help you decide whether to stop breastfeeding or stop using CRYSVITA.
Driving and operating vehicles and machinery
You or your child may experience dizziness while being treated with CRYSVITA. In such cases, certain activities may be dangerous, such as driving vehicles, using tools or machinery, riding a bicycle, horseback riding, or climbing trees.
CRYSVITA contains sorbitol
This medicine contains 45.91 mg of sorbitol per vial, equivalent to 45.91 mg/mL. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or if you (or your child) 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 taking (or administering to your child) this medicine.
CRYSVITA contains polysorbate
This medicine contains 0.5 mg of polysorbate 80 per vial, equivalent to 0.5 mg/mL. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

3. How to use CRYSVITA

CRYSVITA must be administered by injection under the skin (subcutaneous use) in the upper arm, abdomen, buttocks, or thigh. This medicine will be administered to you or your child by a healthcare professional. Alternatively, your doctor may recommend that you administer the injection yourself or to your child. A healthcare professional will show you how to do this. The first self-injection after starting treatment or after a dose adjustment must be performed under the supervision of a healthcare professional. A detailed section on "Instructions for Use" is provided at the end of this leaflet. Always follow these instructions carefully when administering CRYSVITA to yourself or your child.

Use this medicine exactly as directed by your doctor, nurse, or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.

Amount of CRYSVITA needed

The dose is based on body weight. Your doctor will determine the correct dose for you.

Dose for XLH and TIO

The CRYSVITA dose should be injected:

every two weeks in children and adolescents aged 1 to 17 years
every four weeks in adults.

Your doctor will monitor you to ensure you are receiving the correct dose and may adjust the dose or frequency of administration if necessary.

Maximum dose for patients with XLH

The maximum dose you will receive for the treatment of XLH is 90 mg.

Maximum dose for patients with TIO

The maximum dose you will receive for the treatment of TIO

for children aged 1 to 12 years is 90 mg
for adolescents aged 13 to 17 years and adults is 180 mg.

Patients with TIO

If you have TIO and require treatment for the underlying tumour (radiation therapy or surgical removal), your doctor will discontinue treatment with CRYSVITA. Once tumour treatment is complete, your doctor will monitor your serum phosphate levels and will restart CRYSVITA treatment if these levels are low.

If you have received more CRYSVITA than you should

If you think you have been given too much CRYSVITA, inform your doctor immediately.

If you miss a dose of CRYSVITA

If a dose is missed, consult your doctor immediately. The missed dose should be administered as soon as possible, and your doctor will reschedule subsequent doses accordingly.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects in children and adolescents with XLH

Very common (may affect more than 1 in 10 children and adolescents)

Tooth abscess (infection)
Cough
Headache
Dizziness
Vomiting
Nausea
Diarrhoea
Constipation
Dental caries
Rash
Muscle pain (myalgia) and pain in hands and feet
Reactions at the injection site, which may include: redness, rash, pain, itching, swelling, bleeding, or bruising. These injection site reactions are usually mild and occur within one day of the injection; they generally improve within about 1–3 days.
Fever
Low levels of vitamin D in the blood

Common (may affect up to 1 in 10 children/adolescents)

Hives (urticaria)
Increased parathyroid hormone levels in the blood

Uncommon (may affect up to 1 in 100 children/adolescents)

High levels of calcium in the blood

Not known (frequency cannot be estimated from the available data)

High levels of calcium in the urine
Increased phosphate levels or elevated parathyroid hormone levels in the blood

Side effects in children and adolescents with TIO

Side effects in children and adolescents are not known, as clinical studies have not been conducted.

Side effects in adults with XLH and TIO

Very common (may affect more than 1 in 10 adults)

Tooth abscess (infection)
Headache
Dizziness
Restless legs syndrome (an irresistible urge to move the legs to relieve pain, discomfort, or unusual sensations, especially before sleeping or during the night)
Constipation
Back pain
Muscle spasm
Reactions at the injection site, which may include pain or swelling
Low levels of vitamin D in the blood

Common (may affect up to 1 in 10 adults)

Increased or high levels of parathyroid hormone in the blood
High levels of calcium in the blood or in the urine
Rash
Hives (urticaria)
Increased phosphate levels in the blood

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CRYSVITA

Keep CRYSVITA out of the sight and reach of children.
Do not use CRYSVITA after the expiry date which is stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in its outer packaging to protect the medicine from light.
Do not use CRYSVITA if visible particles are present.
Do not dispose of any medicine via wastewater or household waste. This will help protect the environment.
If self-injecting, please refer to Step 5 of the "Instructions for Use" at the end of the package leaflet for instructions on the disposal of unused medicines and provided materials.
For any questions about how to dispose of medicines no longer used, consult your healthcare professional or pharmacist.

6. Package contents and other information

What CRYSVITA contains
The active substance is burosumab. Each vial contains 10, 20 or 30 mg of burosumab.
The other components are L-histidine, D-sorbitol (E 420), polysorbate 80 (E 433), L-methionine, hydrochloric acid 10%, and water for injections. (See "CRYSVITA contains sorbitol" in section 2 for further information).

Description of the appearance of CRYSVITA and contents of the pack
CRYSVITA is supplied as a solution for injection, from clear to slightly opalescent, ranging from colourless to brownish-yellow, in a glass vial. Each pack contains 1 vial.

Marketing Authorization Holder
Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
The Netherlands
[email protected]

Manufacturer
allphamed PHARBIL Arzneimittel GmbH
Hildebrandstr. 10-12
37081 Göttingen
Germany
Kyowa Kirin Holdings B.V.
Bloemlaan 2
2132NP Hoofddorp
The Netherlands

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/. Additionally, links to other websites on rare diseases and related therapeutic treatments are provided.

INSTRUCTIONS FOR USE

Read these Instructions for Use carefully before using CRYSVITA:

Administer the injection to yourself or your child only if your doctor has instructed you to do so.
The injection should only be performed after you have received adequate training on the injection technique. The first self-injection after starting treatment or after a dose adjustment must be performed in the presence of a healthcare professional.
Always use this medicine exactly as instructed by your doctor, pharmacist, or nurse (healthcare professional). If you have any doubts, consult your healthcare professional.
Your doctor will prescribe the correct dose, measured in milligrams (mg). CRYSVITA is available in vials of three different strengths: 10 mg, 20 mg, and 30 mg. Each vial is for single use only. Always use a new vial of CRYSVITA for each injection. Refer to Step 5 for instructions on how to dispose of used vials and other supplied materials.
Your healthcare professional will tell you how much CRYSVITA to administer for yourself or your child. You may need more than one vial to achieve the correct dose for yourself or your child.
If your healthcare professional advises that more than one injection is required to deliver the prescribed dose, repeat Steps 2 to 5 below for each injection. Use new materials and select a different body site for each injection.
Use only the syringe and needles supplied or prescribed by your healthcare professional for the injection.
o Always use the large needle to draw up the liquid, and remember to replace it with the small needle before injecting.
o Using the wrong syringe or needle may result in a dosing error or make the injection more painful.
When CRYSVITA is administered to a young child, it may be helpful to have another person present to assist.
Do not use CRYSVITA if you are allergic to any of the ingredients in this medicine. Stop using CRYSVITA if you experience an allergic reaction during or after the injection and contact your healthcare professional immediately. For further information, refer to section 2 of the Package Leaflet.

Step 1. Gather and inspect the materials provided
Remove the required CRYSVITA vials from the refrigerator.
Check the strength on the label of each vial.
Verify that you have the correct number of vials corresponding to the dose in milligrams (mg), as advised by your healthcare professional.
If you have any doubts, consult your healthcare professional.
Allow the vials to warm to room temperature for 30 minutes. Do not heat the vials in any other way, for example with warm water or in a microwave. Do not expose the vials to direct sunlight.
Record the following information: date of administration, name of the medicine, and batch number (shown on the packaging after "Batch"). Keep this record in a safe place.
Check the expiry date (shown after "Exp.") on the vial label.
Inspect the liquid in the vial without shaking.
Do not use the vial if:

the expiry date has passed
the colour has changed, or if the liquid is cloudy or contains particles. The CRYSVITA solution should be from clear to slightly opalescent and colourless to light brownish-yellow.

Medical diagram with vial A, syringe B, two needles C and D, two gauzes E, biohazard waste container F, adhesive bandage G, and cotton H

Place all necessary materials on a clean, flat surface. For each injection, you will need:
A. CRYSVITA vial for injection
B. One syringe with plunger
C. One large syringe needle for drawing up CRYSVITA
D. One small syringe needle for injecting CRYSVITA
E. Alcohol wipes
F. Sharps container
G. Plaster (if required)
H. Gauze or cotton ball
If you do not have these materials, contact your healthcare professional.
Your healthcare professional will explain the use of the different needles.
The large needle is used to draw CRYSVITA from the vial.
The small needle is used to inject CRYSVITA.
If you have any doubts, consult your healthcare professional before use.
Do not use materials that are missing parts or appear damaged in any way.
Do not remove the cap from a needle until you are ready to use it.
Wash your hands thoroughly with soap and water before proceeding to Step 2.

Step 2. Draw up CRYSVITA and prepare the injection
Remove the seal cap from the vial to expose the rubber stopper.
Clean the rubber stopper with an alcohol wipe and allow it to dry. Do not touch the rubber stopper after cleaning.
Select the large needle and remove it from its sterile packaging, but do not remove the protective cap covering the needle.

Two hands handling two syringes to prepare the injection

Holding the large needle by its protective cap in one hand and the syringe body in the other,
Depending on the materials supplied to you:

you may need to push the needle onto the syringe and twist clockwise to secure it tightly;
or push the needle down until it is firmly attached. Do not touch the needle or the end of the syringe to which it is attached.

Once the needle is securely attached, hold the syringe body with the needle pointing upward.
Remove the cap from the needle by pulling it off.
Do not discard the needle cap.
After removing the cap, do not touch the needle or allow it to come into contact with any other surface.
Do not use the syringe if you drop it after removing the cap or if the needle appears damaged.
Your healthcare professional will tell you the amount of liquid to

Two hands holding a syringe with the needle pointing upward

inject, which will usually be 1 mL per injection.
Your healthcare professional will show you which marking to use if you need to inject less than 1 mL.
Always use the marking corresponding to your dose.
If you have any doubts, consult your healthcare professional before use.
Pull back the syringe plunger until the tip aligns with the marking corresponding to your dose. This fills the syringe with air.

One hand holds a syringe vertically while the

Place the vial on a flat surface.
Slowly insert the large needle through the rubber stopper into the vial.
Avoid letting the tip of the needle touch the liquid in the vial.
If the needle tip touches the liquid, slowly withdraw the needle until it no longer contacts the liquid.
Slowly push the plunger into the syringe to inject the air from the syringe into the vial.

Two hands preparing a syringe with a needle and a glass vial, with a curved black arrow indicating the liquid aspiration movement

Invert the vial while keeping the needle inside.
Ensure the needle tip is at the bottom of the liquid.

Technical drawing showing hands holding a syringe with an enlargement of the graduated cylinder and plunger for injection

Slowly pull back the plunger to fill the syringe until the plunger tip aligns with the marking corresponding to your dose.
Keep the needle tip always submerged in the liquid.
Check for air bubbles in the liquid within the syringe.

Black and white illustration showing hands holding a syringe with air bubbles in the barrel

If you see air bubbles:

hold the syringe vertically with the needle still inside the vial;
gently tap the barrel of the syringe with your finger to move the air bubbles upward;
once the air bubbles rise to the top, slowly push the plunger to expel them.

Check the dose again against the markings on the syringe.
If necessary, draw up more liquid to reach the marking corresponding to your dose.
Recheck for air bubbles and repeat the procedure if needed.
When there are no more air bubbles, remove the syringe with the needle from the vial by pulling downward.

One hand holds an injection pen being pushed horizontally toward a cylindrical device, indicated by a black arrow

Remove the large needle from the syringe.

To do this, place the cap of the large needle on a flat surface.
With one hand, insert the large needle into the cap, sliding it in without using the other hand to avoid injury. Then, with the other hand, secure the cap by snapping it into place.
Depending on the materials available, you will either:
o twist the large needle with its attached cap counterclockwise to remove it from the syringe,
or remove the large needle with its attached cap directly from the syringe and place it into the sharps container.

Select the small needle and remove it from its sterile packaging, but do not remove the protective cap covering the needle.
To attach it to the syringe, hold the small needle by its protective cap with one hand and the syringe body with the other hand.
Depending on the materials supplied to you:

you may need to push the needle onto the syringe and twist clockwise until it is secure,
or push the needle down until it is firmly attached. Do not touch the needle or the end of the syringe to which it is attached.

Step 3. Prepare the injection site

Medical diagram showing anterior and posterior views of a human body with four dark rectangular areas highlighted on the abdomen, thighs, and arms

The injection should be administered into the fatty layer just under the skin. You will need to select an injection site. If you are self-injecting, suitable sites are:

abdomen and upper thighs

If you are injecting another person, suitable sites are:

abdomen, upper thighs, outer area of the upper arms, buttocks

Do not inject:

into an area that is inflamed, red, or bruised, or where the skin is damaged
into an area with stretch marks or scars (including burns)
directly into a mole or the area around a mole

If administering more than one injection, choose a different site for each injection. Cleanse each injection site with a new alcohol wipe and allow the skin to dry.
CRYSVITA must be injected into clean, dry skin.

Step 4. Inject CRYSVITA

Two hands gently lifting the edge of an adhesive bandage or gauze applied to the skin of a limb to remove or reposition it

Remove the cap from the small needle by pulling it off.
Firmly pinch the skin between your thumb and fingers, creating an area about 5 cm in size.
Hold the syringe between the thumb and index finger of your dominant hand.
The needle should be inserted into the skin at a 45° or 90° angle.
Your healthcare professional will show you which angle to use.

Technical drawing showing a hand holding a syringe for injection

One hand holds a syringe angled at 45 degrees to inject liquid into the subcutaneous tissue of the body

Use a quick motion, like throwing a dart, to insert the needle into the pinched skin.
Do not push the plunger when inserting the needle.

One hand pressing the plunger of a syringe downward to inject liquid into a body part indicated by a black arrow

Once the needle is inserted, do not move it.
Continue holding the skin between your fingers.
Slowly push the plunger into the syringe, over up to 30 seconds, until the syringe is empty.
After the full dose has been administered,

One hand holds a syringe in a vertical position while the

complete the injection by gently removing the syringe.
Release the skin between your fingers.
Press a cotton ball or gauze pad over the injection site for a few seconds to stop any bleeding. Apply a plaster if needed.
Do not rub the injection site.
To avoid injury, do not recap the small needle. Dispose of the uncapped needle directly into the sharps container.

Step 5. After each injection
Dispose of used needles, their caps, and syringes in the sharps disposal container. Vials must be disposed of in accordance with local regulations.
Do not throw needles or syringes into household waste.
Do not store vials with leftover medicine for future use, and do not give them to other people.
When the sharps container is nearly full, follow local guidelines to request a new container and for proper disposal.
Reminder: If you are administering more than one injection, repeat Steps 2 to 5 for each injection.
Use new materials for each injection.
Record the date of the injection and all sites where injections were administered, so you can use a different site for the next injection.
A video demonstrating how to prepare and administer the injection is available at the following link:
www.myinject.eu .

Patient Information Leaflet: Information for the User

CRYSVITA 10 mg solution for injection in pre-filled syringe, 20 mg solution for injection in pre-filled syringe, 30 mg solution for injection in pre-filled syringe

burosumab
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

What CRYSVITA is and what it is used for
What you need to know before using CRYSVITA
How to use CRYSVITA
Possible side effects
How to store CRYSVITA
Contents of the pack and other information

1. What CRYSVITA is and what it is used for

What CRYSVITA is
CRYSVITA contains the active substance burosumab, a type of medicine known as a human monoclonal antibody.

What CRYSVITA is used for
CRYSVITA is used for the treatment of X-linked hypophosphataemia (XLH). It is used in children and adolescents aged 1 to 17 years, as well as in adults.
CRYSVITA is used for the treatment of tumour-induced osteomalacia (TIO) in cases where the tumour causing this condition cannot be successfully removed or located, in children and adolescents aged 1 to 17 years, as well as in adults.

What is X-linked hypophosphataemia (XLH)?
X-linked hypophosphataemia (XLH) is a genetic disease.

People affected by XLH have higher levels of a hormone called fibroblast growth factor 23 (FGF23).
FGF23 reduces the amount of phosphate in the blood.
Low phosphate levels can cause:
- inadequate bone hardening and, in children and adolescents, inadequate bone growth
- pain and stiffness in bones and joints.

What is tumour-induced osteomalacia (TIO)?

People affected by TIO have higher levels of a hormone called FGF23, produced by certain types of tumour.
FGF23 reduces the amount of phosphate in the blood.
Low phosphate levels can cause softening of the bones, muscle weakness, fatigue, bone pain, and fractures.

How CRYSVITA works
CRYSVITA binds to FGF23 in the blood, blocking the action of this hormone, and increases the amount of phosphate in the blood, thereby helping to achieve normal levels.

2. What you need to know before using CRYSVITA

Do not use CRYSVITA

if you are allergic to burosumab or to any of the other ingredients of this medicine (listed in section 6)
if you are taking phosphate supplements or certain vitamin D supplements (containing so-called active vitamin D, e.g. calcitriol)
if you already have high levels of phosphate in your blood ("hyperphosphatemia")
if you have severe kidney disease or kidney failure.

Allergic reactions
Stop taking CRYSVITA and contact your doctor immediately if any of the following side effects occur, as they may be signs of an allergic reaction:

rash and itching all over the body
severe swelling of the eyelids, mouth or lips (angioedema)
shortness of breath
rapid heartbeat
sweating.

If any of the above conditions apply to you, do not take CRYSVITA. If in doubt, consult your doctor before using CRYSVITA.
Warnings and precautions
Skin reactions
Skin reactions may occur at the injection site; see section 4 for further information. If these reactions are severe, inform your doctor.
Tests and monitoring
Your doctor will monitor phosphate and calcium levels in your blood and urine and may perform a kidney ultrasound before and during treatment to reduce the risk of hyperphosphatemia (excess phosphate in the blood), hypercalcemia (excess calcium in the blood), and ectopic mineralization (calcium buildup in tissues such as the kidneys). Your serum parathyroid hormone level will also be checked before and during treatment to reduce the risk of hyperparathyroidism (excess parathyroid hormone in the blood).
Children under 1 year of age
CRYSVITA must not be administered to children under 1 year of age, as the safety and effects of the medicine have not been studied in this age group.
Treatment notes
If you self-administer the medicine or administer it to your child, you should record the following information: date of administration, name of the medicine, and batch number (shown on the packaging after "Batch"). Keep these records in a safe place. If you have any questions, consult your doctor, nurse, or pharmacist.
Other medicines and CRYSVITA
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take CRYSVITA and inform your doctor if you are taking:

phosphate supplements
certain vitamin D supplements (containing so-called active vitamin D, e.g. calcitriol). There are some vitamin D supplements that you may continue or start using; your doctor will advise you which ones.

Consult your doctor before taking CRYSVITA:

if you are taking medicines that act like calcium in the body ("calcimimetics"). Your doctor may monitor your calcium levels more closely.
if you have TIO and are about to receive treatment for the underlying tumour (radiation therapy or surgical removal). In this case, treatment with CRYSVITA will only begin after treatment of the underlying tumour and if serum phosphate levels are low.
if you have problems related to the parathyroid glands.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine, as the effects of CRYSVITA on the baby are unknown.
CRYSVITA is not recommended during pregnancy.
If you are of childbearing potential, you must use an effective method of contraception (birth control) during treatment with CRYSVITA and for at least 14 weeks after your last dose. Discuss this with your doctor.
It is known that monoclonal antibodies such as CRYSVITA pass into breast milk during the first few days after birth, but after this initial period CRYSVITA may be used. Talk to your doctor about using CRYSVITA while breastfeeding so that they can help you decide whether to stop breastfeeding or stop using CRYSVITA.
Driving, cycling, and operating machinery
You or your child may experience dizziness while being treated with CRYSVITA. In this case, certain activities may be dangerous, such as driving vehicles, using tools or machinery, cycling, horse riding, or climbing trees.
CRYSVITA contains sorbitol
CRYSVITA 10 mg solution for injection in pre-filled syringe: this medicine contains 15.30 mg of sorbitol per pre-filled syringe.
CRYSVITA 20 mg solution for injection in pre-filled syringe: this medicine contains 30.61 mg of sorbitol per pre-filled syringe.
CRYSVITA 30 mg solution for injection in pre-filled syringe: this medicine contains 45.91 mg of sorbitol per pre-filled syringe.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which a person cannot break down fructose, talk to your doctor before taking (or administering to your child) this medicine.
CRYSVITA contains polysorbate
CRYSVITA 10 mg solution for injection in pre-filled syringe: this medicine contains 0.165 mg of polysorbate 80 per pre-filled syringe, equivalent to 0.5 mg/mL.
CRYSVITA 20 mg solution for injection in pre-filled syringe: this medicine contains 0.335 mg of polysorbate 80 per pre-filled syringe, equivalent to 0.5 mg/mL.
CRYSVITA 30 mg solution for injection in pre-filled syringe: this medicine contains 0.5 mg of polysorbate 80 per pre-filled syringe, equivalent to 0.5 mg/mL.
Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.