What is Natpar?

Natpar is a hormone replacement for adults with under-active parathyroid glands, a condition known as ‘hypoparathyro­idism’.

54917v8

6507184

Hypoparathyroidism is a disease caused by low levels of parathyroid hormone, which is produced by the parathyroid glands in the neck. This hormone controls the amount of calcium and phosphate in the blood and urine.

If your levels of parathyroid hormone are too low, you can have low blood calcium. Low calcium can cause symptoms in many parts of your body, including the bones, heart, skin, muscles, kidneys, brain and nerves. For a list of symptoms of low calcium, see section 4.

Natpar is a synthetic form of parathyroid hormone that helps you keep calcium and phosphate levels in your blood and urine at a normal level.

Natpar contains sodium

This medicinal product contains less than 1 mmol (23 mg) sodium per dose. This means that it is essentially “sodium-free”.

QWhen preparing to inject a dose, be sure to remove your Natpar cartridge from the refrigerator. Note: You should store your cartridge in the refrigerator at all times, except when preparing and injecting your medicine.

Getting to know the parts of your Natpar pen and your Natpar medicine

Preparing your Natpar pen

Preparing and mixing your Natpar

Giving your daily dose

If you require assistance at any time, contact your doctor, pharmacist or nurse.

You may also contact Takeda at +44(0) 3333 000181

or email at.

Getting to know the parts of your Natpar pen and your Natpar medicine

Get to know the Natpar pen components Parts of your Natpar pen

Note: The rod protector (dummy cartridge) protects the rod during shipment from the factory. Throw away the rod protector when you are ready to use your pen.

Dose Window Dosage Knob Injection Button

• Wash and dry your hands.
• Gather your supplies, including:

° Your mixing device

° New Natpar cartridge from the refrigerator

° New disposable pen needle

° Puncture resistant sharps container

° A pencil or pen to write the dates you mix your cartridge

° Your medicine cartridge tracker (located within this instructions for use)

° Your Natpar pen to inject your medicine

° This instructions for use

Fill in the dates in your medicine cartridge tracker.

Medicine cartridge tracker

Instructions:

• Enter today’s date in the space next to “Date mixed.”
• Enter the date 14 days from today in the space next to “Discard on” (Same day of the week, 2 weeks later).
• Dispose of your cartridge on the “Discard on” date even if you have medicine left in your cartridge. Do not use your cartridge on the “Discard on” date.
• A pen needle must be attached to mix a new cartridge.

^3.^ Remove the paper tab from the needle cap.

Cap

Your Natpar cartridge

Rod Protector (dummy cartridge)

Base

Your Natpar cartridge contains medicine powder and solvent to mix the powder with. You must mix the powder and the solvent in the cartridge before using your Natpar pen.

• Each cartridge contains 14 doses.
• The dose indicator shows you the number of doses left in the cartridge.

D Screw the Pen Needle onto the cartridge in a clockwise direction.

• Ensure the Pen Needle is straight and tight on the cartridge (the wider edge of the needle cap must touch the ‘shoulder’ of the cartridge)
• Do not remove the needle cap or guard until you are ready to give your medicine.

Dose Indicator Powder Liquid

OTurn the wheel of the mixing device in a counterclockwise direction to lower the rod if it is not already lowered.

Other supplies that are needed:

Note: The alcohol swabs, injection needles and the puncture resistant container are not included in the pack.

The Medicine Cartridge Tracker is located within this instructions for use.

Medicine Cartridge Tracker

Use the alcohol swab to clean the injection area.

• Make sure the rod in the mixing device looks like this (completely retracted).

O Screw the Natpar cartridge onto your mixing device in a clockwise direction.

• The pen needle must be firmly attached.

Needle Cap Paper Tab Needle Guard Needle

Mixing Device

O With the needle cap pointing up , turn the wheel slowly in a clockwise direction until the stoppers within the cartridge no longer move and until the wheel turns freely.

• Keep the needle pointing up.
• Do NOT hold the mixing device at an angle.

(Puncture resistant container example)

^8.^ Make sure the stoppers look like this and stay together.

Preparing and mixing your Natpar

You need to mix Natpar before you can use it. Once the medicine is mixed, it can be used for up to 14 injections (14 doses).

If this is your first time using Natpar by yourself, your doctor or nurse will guide you through how to mix your Natpar cartridge.

400 × 700mm

No

10 February 2022

Univers LT Std, Wingdings 3

MySGS No: 6683802 Internal Loop: 0 Artworker: US

Tech Spec Key

Pharma Code Varnish Free

Profile Perforation

Text Free Print Free Velcro Area

Text Area

Fold

Glue Dots Velcro Dots Braille Grid

Area for lot and use by date

• OHold the mixing device with the attached cartridge, with the needle pointed up, and gently move the cartridge from side to side (from 9 o’clock to 3 o’clock) about 10 times to dissolve the powder that is in the cartridge. Do NOT shake the cartridge. Ensure the needle is pointing up.
• Put the mixing device down with the cartridge attached and wait for 5 minutes to allow complete dissolution of the powder.

Check the solution before giving every daily dose. If the solution is cloudy, contains visible particles, or is not colourless after 5 minutes, do not use this medicine. Contact your doctor, pharmacist or nurse. It is normal to see small bubbles.

With the needle cap pointing up, screw the cartridge onto the pen in a clockwise direction until there is no space between the cartridge and the pen.

Q Priming your Natpar pen.

Turn the dosage knob in a clockwise direction until “GO ” lines up with the notch in the dose window.

Preparing your Natpar pen

You will prepare your Natpar pen once every 14 days.

1.^ Pick up your pen and remove the cap. Save the cap for later use.

Press the injection button. You should see “0 ” line up with the notch in the dose window. If you do not see “0 ” line up, press the injection button until it is lined up.

Unscrew the rod protector (dummy cartridge ) or the empty medicine cartridge in a counterclockwise direction and throw it in a puncture resistant sharps container.

Attaching a new needle.

• Remove the paper tab from the needle cap.
• Firmly hold the Natpar pen upright.
• While keeping the needle cap straight, screw it firmly onto the cartridge in a clockwise direction (the wider edge of the needle cap must touch the ‘shoulder’ of the cartridge).
• Leave the needle cap on.

Q Lower the rod. If the rod is extended, turn the dark red ring counterclockwise to lower it. Do not tighten the ring too much.

Q Check the rod. It will have a small gap when done the right way.

QHold the pen so you can see “GO ” in the dose window with the pen needle pointing down.

14.^ Read steps 15 , 16 , and 17 carefully before you inject the medicine.

Q Insert the needle fully into your thigh (you can pinch a fold of the skin if told by your doctor or nurse). Make sure you can see “GO ” in the window.

O Unscrew the cartridge from the mixing device in a counterclockwise direction and put the mixing device down.

O Attach the cartridge to the pen. Pick up the pen base and hold it with the rod pointed upright.

Hold the pen with the needle cap pointing up.

Q Press the injection button on a flat surface, such as a table top, until the “0 ” lines up with the notch in the dose window.

• It is normal for 1 or 2 drops of liquid to appear on the needle during this step.
• Do not remove the medicine cartridge from the pen until the “Discard on” date or the cartridge is empty.
• Prime your pen only 1 time for each new cartridge.

Wipe the injection area of your thigh with an alcohol swab. Inject into an alternate thigh each day.

Hold the Natpar pen with the needle pointing straight down.

• Keep the needle pointing down until the injection is complete.

Hold the pen so you can see the dose window.

Giving your daily dose

NOTE: If you have just finished mixing your medicine and preparing your pen and the pen needle is on, go straight to “Before injecting your daily dose” (step 6 in this section) for instructions on how to inject using your Natpar pen.

If you need help at any time, ask your doctor or nurse.

^.^ Wash and dry your hands.

O Gather your supplies, including:

• Your Natpar pen from the refrigerator
• New disposable pen needle
• Puncture resistant sharps container
• Alcohol swab

Note: You should store your mixed cartridge within the pen in the refrigerator at all times, except when preparing and injecting your medicine.

Check the cartridge.

Remove the pen cap from your Natpar pen. The mixed cartridge should be inside.

Q Before attaching a new needle to your pen, check:

• If the solution is clear, colourless and free from visible particles. It is normal to see small bubbles.

If the liquid is not clear, colourless or free from visible particles, do not use this medicine. Contact your doctor, pharmacist or nurse.

You will have to prepare a new Natpar cartridge if:

• There are no remaining doses in the pen (dose counter at “0”)

or

• The “Discard on” date has been reached (see medicine tracker).

Gently tap the cartridge 3 to 5 times. This moves any air bubbles away from the needle.

Before injecting your daily dose.

• Do NOT use a cartridge that has been frozen.
• Discard all mixed cartridges if the “Discard on” date has been reached (see medicine tracker).

Make sure the needle cap is pointing downward at all times during step 8 to step 17.

Turn the dosage knob until “GO ” lines up with the notch in the window. Do not turn the dosage knob past “GO.”

• If the dosage knob is hard to turn, you may not have enough liquid left.

Check the dose indicator on the cartridge to see if there are any doses left or check the “Discard on ” date on the medicine cartridge tracker to see if it has been more than 14 days.

Prepare the pen needle for giving the injection.

Without unscrewing,

• Pull the needle cap straight off and set it aside.
• Then pull off the needle guard and discard it.

Project No I 22020209572­8318 Pass No I 1 Description NATPAR PIL XU MultiS 220202095728318

DAL/Version No 54917v8 Product Commercial Name NATPAR

400 × 700mm

No

10 February 2022

Univers LT Std, Wingdings 3

MySGS No: 6683802 Internal Loop: 0 Artworker: US

Tech Spec Key

The Natpar cartridges and any pen that contains a mixed cartridge should always be stored in the refrigerator (2°C – 8°C).

• Do NOT freeze your Do NOT use a cartridge that has Discard all mixed cartridges cartridge. been frozen. older than 14 days.

Place the Natpar pen in the refrigerator.

If you require assistance at any time, contact your doctor, pharmacist or nurse.

You may also contact Takeda at +44(0) 3333 000181

or email at.

What you need to know before getting started

• Do NOT use your Natpar pen until your doctor or nurse has shown you how to use it.
• Use these instructions for use every time you mix your medicine, prepare your pen, or give an injection so you do not forget to do a step.
• A new needle must be attached to the pen every day.
• A new cartridge should be prepared once every 14 days.
• Do NOT use this medicine if you notice that it has become cloudy, coloured, or contain visible particles.
• Always store the cartridge in the refrigerator (at 2°C – 8°C).
• Do NOT freeze your cartridge.
• Do NOT use a cartridge that has been frozen.
• Discard all mixed cartridges older than 14 days.
• Only take your dose once per day.
• To clean your Natpar pen, wipe the outside of the pen with a damp cloth. DO NOT place the pen in water or wash or clean it with any liquid.
• Throw away the used Natpar cartridge and used needles as instructed by your doctor, pharmacist or nurse.
• Your Natpar pen can be re-used for up to 2 years.

Getting to know the parts of your Natpar pen and your Natpar medicine

Get to know the Natpar pen components Parts of your Natpar pen

Note: The rod protector (dummy cartridge) protects the rod during shipment from the factory. Throw away the rod protector when you are ready to use your pen.

Dose Window Dosage Knob Injection Button

• Wash and dry your hands.
• Gather your supplies, including:

° Your mixing device

° New Natpar cartridge from the refrigerator

° New disposable pen needle

° Puncture resistant sharps container

° A pencil or pen to write the dates you mix your cartridge

° Your medicine cartridge tracker (located within this instructions for use)

° Your Natpar pen to inject your medicine

° This instructions for use

Fill in the dates in your medicine cartridge tracker.

Medicine cartridge tracker

Instructions:

• Enter today’s date in the space next to “Date mixed.”
• Enter the date 14 days from today in the space next to “Discard on” (Same day of the week, 2 weeks later).
• Dispose of your cartridge on the “Discard on” date even if you have medicine left in your cartridge. Do not use your cartridge on the “Discard on” date.
• A pen needle must be attached to mix a new cartridge.

^3.^ Remove the paper tab from the needle cap.

Cap

Your Natpar cartridge

Rod Protector (dummy cartridge)

Base

Your Natpar cartridge contains medicine powder and solvent to mix the powder with. You must mix the powder and the solvent in the cartridge before using your Natpar pen.

• Each cartridge contains 14 doses.
• The dose indicator shows you the number of doses left in the cartridge.

D Screw the Pen Needle onto the cartridge in a clockwise direction.

• Ensure the Pen Needle is straight and tight on the cartridge (the wider edge of the needle cap must touch the ‘shoulder’ of the cartridge)
• Do not remove the needle cap or guard until you are ready to give your medicine.

Dose Indicator Powder Liquid

OTurn the wheel of the mixing device in a counterclockwise direction to lower the rod if it is not already lowered.

Other supplies that are needed:

Note: The alcohol swabs, injection needles and the puncture resistant container are not included in the pack.

The Medicine Cartridge Tracker is located within this instructions for use.

Medicine Cartridge Tracker

Use the alcohol swab to clean the injection area.

• Make sure the rod in the mixing device looks like this (completely retracted).

Disposable needle (Exploded view)

O Screw the Natpar cartridge onto your mixing device in a clockwise direction.

• The pen needle must be firmly attached.

Needle Cap Paper Tab Needle Guard Needle

Mixing Device

O With the needle cap pointing up , turn the wheel slowly in a clockwise direction until the stoppers within the cartridge no longer move and until the wheel turns freely.

• Keep the needle pointing up.
• Do NOT hold the mixing device at an angle.

(Puncture resistant container example)

^8.^ Make sure the stoppers look like this and stay together.

Preparing and mixing your Natpar

You need to mix Natpar before you can use it. Once the medicine is mixed, it can be used for up to 14 injections (14 doses).

If this is your first time using Natpar by yourself, your doctor or nurse will guide you through how to mix your Natpar cartridge.

400 × 700mm

No

10 February 2022

Univers LT Std, Wingdings 3

MySGS No: 6683802 Internal Loop: 0 Artworker: US

Tech Spec Key

Pharma Code Varnish Free

Profile Perforation

Text Free Print Free Velcro Area

Text Area

Fold

Glue Dots Velcro Dots Braille Grid

Area for lot and use by date

• OHold the mixing device with the attached cartridge, with the needle pointed up, and gently move the cartridge from side to side (from 9 o’clock to 3 o’clock) about 10 times to dissolve the powder that is in the cartridge. Do NOT shake the cartridge. Ensure the needle is pointing up.
• Put the mixing device down with the cartridge attached and wait for 5 minutes to allow complete dissolution of the powder.

Check the solution before giving every daily dose. If the solution is cloudy, contains visible particles, or is not colourless after 5 minutes, do not use this medicine. Contact your doctor, pharmacist or nurse. It is normal to see small bubbles.

With the needle cap pointing up, screw the cartridge onto the pen in a clockwise direction until there is no space between the cartridge and the pen.

Q Priming your Natpar pen.

Turn the dosage knob in a clockwise direction until “GO ” lines up with the notch in the dose window.

Preparing your Natpar pen

You will prepare your Natpar pen once every 14 days.

1.^ Pick up your pen and remove the cap. Save the cap for later use.

Press the injection button. You should see “0 ” line up with the notch in the dose window. If you do not see “0 ” line up, press the injection button until it is lined up.

Unscrew the rod protector (dummy cartridge ) or the empty medicine cartridge in a counterclockwise direction and throw it in a puncture resistant sharps container.

Attaching a new needle.

• Remove the paper tab from the needle cap.
• Firmly hold the Natpar pen upright.
• While keeping the needle cap straight, screw it firmly onto the cartridge in a clockwise direction (the wider edge of the needle cap must touch the ‘shoulder’ of the cartridge).
• Leave the needle cap on.

Q Lower the rod. If the rod is extended, turn the dark red ring counterclockwise to lower it. Do not tighten the ring too much.

Q Check the rod. It will have a small gap when done the right way.

QHold the pen so you can see “GO ” in the dose window with the pen needle pointing down.

14.^ Read steps 15 , 16 , and 17 carefully before you inject the medicine.

Q Insert the needle fully into your thigh (you can pinch a fold of the skin if told by your doctor or nurse). Make sure you can see “GO ” in the window.

O Unscrew the cartridge from the mixing device in a counterclockwise direction and put the mixing device down.

O Attach the cartridge to the pen. Pick up the pen base and hold it with the rod pointed upright.

Hold the pen with the needle cap pointing up.

Q Press the injection button on a flat surface, such as a table top, until the “0 ” lines up with the notch in the dose window.

• It is normal for 1 or 2 drops of liquid to appear on the needle during this step.
• Do not remove the medicine cartridge from the pen until the “Discard on” date or the cartridge is empty.
• Prime your pen only 1 time for each new cartridge.

Wipe the injection area of your thigh with an alcohol swab. Inject into an alternate thigh each day.

Hold the Natpar pen with the needle pointing straight down.

• Keep the needle pointing down until the injection is complete.

Hold the pen so you can see the dose window.

Giving your daily dose

NOTE: If you have just finished mixing your medicine and preparing your pen and the pen needle is on, go straight to “Before injecting your daily dose” (step 6 in this section) for instructions on how to inject using your Natpar pen.

If you need help at any time, ask your doctor or nurse.

^.^ Wash and dry your hands.

O Gather your supplies, including:

• Your Natpar pen from the refrigerator
• New disposable pen needle
• Puncture resistant sharps container
• Alcohol swab

Note: You should store your mixed cartridge within the pen in the refrigerator at all times, except when preparing and injecting your medicine.

Check the cartridge.

Remove the pen cap from your Natpar pen. The mixed cartridge should be inside.

Q Before attaching a new needle to your pen, check:

• If the solution is clear, colourless and free from visible particles. It is normal to see small bubbles.

If the liquid is not clear, colourless or free from visible particles, do not use this medicine. Contact your doctor, pharmacist or nurse.

You will have to prepare a new Natpar cartridge if:

• There are no remaining doses in the pen (dose counter at “0”)

or

• The “Discard on” date has been reached (see medicine tracker).

Gently tap the cartridge 3 to 5 times. This moves any air bubbles away from the needle.

Before injecting your daily dose.

• Do NOT use a cartridge that has been frozen.
• Discard all mixed cartridges if the “Discard on” date has been reached (see medicine tracker).

Make sure the needle cap is pointing downward at all times during step 8 to step 17.

Turn the dosage knob until “GO ” lines up with the notch in the window. Do not turn the dosage knob past “GO.”

• If the dosage knob is hard to turn, you may not have enough liquid left.

Check the dose indicator on the cartridge to see if there are any doses left or check the “Discard on ” date on the medicine cartridge tracker to see if it has been more than 14 days.

Prepare the pen needle for giving the injection.

Without unscrewing,

• Pull the needle cap straight off and set it aside.
• Then pull off the needle guard and discard it.

Project No I 22020209572­8318 Pass No I 1 Description NATPAR PIL XU MultiS 220202095728318

DAL/Version No 54917v8 Product Commercial Name NATPAR

400 × 700mm

No

10 February 2022

Univers LT Std, Wingdings 3

MySGS No: 6683802 Internal Loop: 0 Artworker: US

Tech Spec Key

The Natpar cartridges and any pen that contains a mixed cartridge should always be stored in the refrigerator (2°C – 8°C).

• Do NOT freeze your Do NOT use a cartridge that has Discard all mixed cartridges cartridge. been frozen. older than 14 days.

Place the Natpar pen in the refrigerator.

How to store your medicine

Pull the needle straight out of your thigh.

• It is normal to see 1 or 2 drops of liquid appear on the needle during this step.
• If you do not think you received your full dose, do not take another dose. Call your doctor. You may need to take calcium and vitamin D.

Carefully recap the exposed needle with the large needle cap by using a scooping technique.

• Make sure that the needle is pressed all the way into the cap.

Q Discard the used needle into a puncture resistant container.

Ask your doctor, pharmacist or nurse how to properly dispose of a full puncture resistant container.

Pharma Code Varnish Free Text Free Print Free Velcro Area Text Area

• O O O O Area for lot and

Profile Perforation Fold Glue Dots Velcro Dots Braille Grid use by date

Put the cap back on your pen.

• A cartridge must be attached to the pen before you can put the pen cap on.

• Line up the pocket clip of the tab on the pen.

• Press the cap and pen together until you hear it click.