PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 300 mg

NDC 0169-2081-03 List : 208103
**Alhemo****®**
**(concizumab-mtci) injection**

300 mg/3 mL(100 mg/mL)

Prefilled Pen

For subcutaneous use only

1x3 mL single-patient use prefilled pen

Dials in 1 mg increments and contains

300 mg total

Rx only

ATTENTION: Dispense the enclosed Medication Guide to each patient.

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DESCRIPTION SECTION

11 DESCRIPTION

Concizumab-mtci, is a humanized IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells with an approximate molecular weight of 149 kDa.

Alhemo (concizumab-mtci) injection is a clear to slightly opalescent, and colorless to slightly yellow solution that may contain translucent to white particles. Alhemo is supplied as a single-patient-use prefilled pen for subcutaneous injection.

Each 1 mL of Alhemo single-patient-use prefilled pen (60 mg/1.5 mL) contains 40 mg active ingredient concizumab-mtci. Each 1 mL of Alhemo single-patient- use prefilled pen (150 mg/1.5 mL) contains 100 mg active ingredient concizumab-mtci. Each 1 mL of Alhemo single-patient-use prefilled pen (300 mg/3 mL) contains 100 mg active ingredient concizumab-mtci.

Each 1 mL of Alhemo single-patient-use prefilled pen contains the following excipients: arginine hydrochloride (5.27 mg), histidine (5.12 mg), phenol (3.5 mg), polysorbate 80 (0.25 mg), sodium chloride (1.46 mg), sucrose (51.3 mg), and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH to 6.

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DOSAGE & ADMINISTRATION SECTION

Highlight: Administer Alhemo by subcutaneous injection to the abdomen or thigh with daily rotation of injection sites. (2.2)

Recommended dosing regimen:

o

Day 1: Loading dose of 1 mg/kg 

o

Day 2: Once-daily dose of 0.2 mg/kg until individualization of maintenance dose (see below) 

▪

4 weeks after initiation of treatment: For dose optimization, measure concizumab‑mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of next scheduled dose. An FDA-authorized test for the measurement of concizumab-mtci concentration in plasma is not currently available.

o

Once the concizumab-mtci concentration result is available, individualize the maintenance dose of Alhemo no later than 8 weeks after initiation of treatment, based on the following concizumab‑mtci plasma concentrations:

▪

Less than 200 ng/mL: adjust to a once-daily dose of 0.25 mg/kg (2.1)

▪

200 to 4,000 ng/mL: continue once-daily dose of 0.2 mg/kg (2.1)

▪

Greater than 4,000 ng/mL: adjust to a once-daily dose of 0.15 mg/kg (2.1)

•

See full Prescribing Information for important preparation and administration instructions. (2.3, 2.4) 

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

For subcutaneous use only.

Alhemo should be administered once-daily. Avoid missed doses.

Recommended dosing regimen:

•

Day 1: Loading dose of 1 mg/kg 

•

Day 2: Once-daily dose of 0.2 mg/kg until individualization of maintenance dose (see below) 

o

4 weeks after initiation of treatment: For dose optimization measure concizumab-mtci plasma concentration by Concizumab Enzyme-Linked Immunosorbent Assay (ELISA) prior to administration of next scheduled dose. An FDA-authorized test for the measurement of concizumab-mtci concentration in plasma is not currently available. 

•

Once the concizumab-mtci concentration result is available, individualize the maintenance dose of Alhemo no later than 8 weeks after initiation of treatment, based on the following concizumab-mtci‑ plasma concentrations:

o

Less than 200 ng/mL: adjust to a once-daily dose of 0.25 mg/kg

o

200 to 4,000 ng/mL: continue once-daily dose of 0.2 mg/kg

o

Greater than 4,000 ng/mL: adjust to a once-daily dose of 0.15 mg/kg

The calculated dose is rounded off to the nearest injectable dose as follows:

•

60 mg/1.5 mL (40 mg/mL) in increments of 0.4 mg (brown label)

•

150 mg/1.5 mL (100 mg/mL) in increments of 1 mg (gold label)

•

300 mg/3 mL (100 mg/mL) in increments of 1 mg (white label)

Additional measurements of concizumab-mtci plasma concentration should be taken at routine clinical follow-ups provided the patient has been on the same maintenance dose for 8 weeks of treatment to ensure steady-state plasma concentration. Maintenance of concizumab plasma concentration above 200 ng/mL is important to decrease the risk of bleeding episodes. If concizumab-mtci plasma concentration remains below 200 ng/mL at two consecutive measurements, the benefits of continued Alhemo treatment should be evaluated versus the potential risk of bleeding events, and alternative therapies if available should be considered.

As Alhemo is dosed by body weight (mg/kg), it is important to recalculate the dose when patients experience body weight changes.

Missed Dose

Adherence to daily dosing of Alhemo is important to maintain protection against bleeding. This is especially important during the initial 4 weeks of treatment to ensure a correct maintenance dose is established. Patients who miss a dose during the initial 4-week period should inform their healthcare professional and resume once-daily dosing at the initial 0.2 mg/kg dose level.

Missed Doses Once the Maintenance Dose Has Been Established

The following dosing guidelines should applyONLY when a patient has forgotten to or neglected to take their once-daily maintenance dose:

•

1 missed dose: Resume once-daily treatment at the maintenance dose level

•

2 to 6 missed doses: Resume treatment with a double dose followed by once-daily treatment at the maintenance dose level

•

7 or more missed doses: Physician should be contacted, and a new loading dose should be considered [see Recommended Dosage (2.1)]

Management of Breakthrough Bleeds

No dose adjustment of Alhemo is required in the case of breakthrough bleeds.

Management in the Perioperative Setting

No dose adjustment of Alhemo is required in the case of minor surgeries.

As there is limited experience in the perioperative setting, it is generally recommended to pause Alhemo at least 4 days prior to major surgery. Alhemo therapy can be resumed 10 to 14 days after surgery on the same maintenance dose without a new loading dose, considering the overall clinical picture of the patient. If necessary, consult a physician experienced in surgery of patients with bleeding disorders.

Immune Tolerance Induction

The safety and efficacy of concomitant use of Alhemo in patients receiving ongoing Immune Tolerance Induction (ITI), a desensitization strategy for the eradication of inhibitors, have not been established, and no data are available. Careful assessment of the potential benefits and risks should be performed if continuation or initiation of Alhemo during ITI is considered.

2.2 Changing to Alhemo from Other Hemostatic Products

•

Discontinue treatment with rFVIIa at least 12 hours before starting Alhemo. 

•

Discontinue treatment with activated prothrombin complex concentrate (aPCC) at least 48 hours before starting Alhemo.

•

Discontinue prophylactic use of standard half-life factor VIII (FVIII) or factor IX (FIX) at least 24 hours before starting Alhemo.

•

When changing from other products to Alhemo, the half-life of the previous product should be considered.

Healthcare providers should discuss with patients receiving Alhemo and/or their caregivers the dose and schedule of bypassing agents or FVIII or FIX, if required, while receiving Alhemo prophylaxis.

2.3 Instructions and Dosage Modification for Bypassing Agents for

Breakthrough Bleeding

Treatment with all bypassing agents (e.g., rFVIIa or aPCC) can be used for breakthrough bleeds, and the dose and duration will depend on the location and severity of the bleed.

For mild and moderate bleeds that require additional treatment with bypassing agents (e.g., rFVIIa or aPCC), the lowest-approved dose and the dose interval in the approved product labeling is recommended. For aPCC, a maximum dose of 100 units/kg body weight within 24 hours is recommended.

For severe bleeds, follow the dosing instructions provided in the approved labeling for the specific product based on clinical judgement.

2.4 Administration and Use Instructions

Treatment is intended for use under the guidance of a healthcare provider. Treatment should be initiated in a non-bleeding state.

Alhemo may be self-administered or administered by a caregiver after appropriate training and reading the Instructions for Use, if a healthcare provider determines that is appropriate.

Administer Alhemo by subcutaneous injection to the abdomen or thigh with rotation of injection site every day. Subcutaneous injections should not be given in areas where the skin is tender, bruised, red or hard, or areas where there are moles, scars, or stretch marks. Children and lean patients should be instructed to use injection techniques that minimize risk of intramuscular injection, e.g. injecting into a pinched fold of skin.

Always use a new needle for each injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Alhemo is a clear to slightly opalescent and colorless to slightly yellow solution that may contain translucent to white particles. Do not use if the solution is discolored.

Each Alhemo prefilled pen is for use by a single patient. An Alhemo pen must not be shared between patients, even if the needle is changed.

Alhemo is recommended to be used with NovoFine® or NovoFine® Plus needles with a gauge of 32 and a length of 4 mm. If needles longer than 4 mm are used, injection techniques that minimize the risk of intramuscular injection should be used.

Instructions for delivering the dosage are provided in the Instructions for Use leaflet enclosed with each Alhemo single-patient-use prefilled pen.

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CONTRAINDICATIONS SECTION

Highlight: Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients. (4)

4 CONTRAINDICATIONS

Alhemo is contraindicated in patients with a history of known serious hypersensitivity to Alhemo or its components or the inactive ingredients [see Warnings and Precautions (5.1), Description (11)].

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NONCLINICAL TOXICOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been conducted to evaluate the carcinogenic potential of concizumab-mtci nor have studies been performed to determine the effects of concizumab-mtci on genotoxicity.

In a 26-week toxicity study in sexually mature male and female cynomolgus monkeys with subcutaneous doses up to 9 mg/kg/day (corresponding to 3400-fold the human exposure, based on AUC0 to 24h), concizumab-mtci did not affect fertility (testicular size, sperm functionality or menstrual cycle duration) and did not cause any changes in the male or female reproductive organs.

13.2 Animal Toxicology and/or Pharmacology

Pharmacology mediated formation of thrombi manifested in cynomolgus monkeys dosed subcutaneously during toxicology studies of 13-weeks (≥10 mg/kg/day), 26-weeks (≥3 mg/kg/day) and 52-weeks (≥1 mg/kg/day) in duration corresponding to ≥3732-fold, ≥955-fold and ≥308-fold, respectively, the human clinical exposure based on AUC0 to 24h in patients with Hemophilia A or B at the MRHD.

In a 28-day drug-drug interaction toxicity study in cynomolgus monkey with daily dosing of 1 mg/kg concizumab-mtci to achieve steady state, three consecutive intravenous doses of up to 1 mg/kg rFVIIa were administered with 2-hour intervals to the concizumab-mtci dosed animals. No adverse findings were observed at a concizumab-mtci exposure corresponding to 205-fold the human exposure, based on AUC0 to 24h.

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INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

•

Thromboembolic events: Inform patients of the signs and symptoms of thromboembolic events, including swelling, warmth, pain, or redness of the skin (and that these could be symptoms of a blood clot in the legs or arms); shortness of breath or severe chest pain (and that these could be symptoms of blood clots in the chest [heart and lungs]).; headache, confusion, difficulty with speech or movement, numbness of the face, eye pain or swelling, or vision problems (and that these could be symptoms of a blood clot in the brain or eyes); or sudden pain in the stomach or lumbar area (and that these could be symptoms of blood clots in the gut or kidneys). Advise patients to contact their healthcare provider for mild reactions and to seek urgent medical attention for moderate to severe reactions [see Warnings and Precautions (5.1)].

o

In conditions in which tissue factor is overexpressed (e.g., advanced atherosclerotic disease, crush injury, cancer, or septicemia), there may be a risk of thromboembolic events or disseminated intravascular coagulation (DIC) with Alhemo treatment. 

•

Hypersensitivity: Inform patients of the early signs of hypersensitivity reactions, including rash, redness, hives, and itching, facial swelling, tightness of the chest, and wheezing as well the signs of an anaphylactic reaction such as itching on large areas of skin; redness and/or swelling of lips, tongue, face, or hands; difficulty swallowing; shortness of breath; wheezing; tightness of the chest; pale and cold skin; fast heartbeat; or dizziness/low blood pressure. Advise patients to discontinue use of Alhemo immediately and contact their healthcare provider if any signs or symptoms occur [see Warnings and Precautions (5.2)].

Advise patients on the importance of adherence to daily dosing and to speak with their healthcare provider before discontinuing treatment with Alhemo as patients who are not adhering to daily dosing or stop treatment with Alhemo may no longer be protected against bleeding.

Advise patients to follow the recommendations regarding proper sharps disposal provided in the FDA-approved Instructions for Use.

Patent Information: http://novonordisk-us.com/products/product- patents.html

Alhemo® is a registered trademark of Novo Nordisk Health Care AG.

NovoFine®, NovoFine® Plus, and Novo Nordisk® are registered trademarks of Novo Nordisk A/S.

For information about Alhemo contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-844-668-6732

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License No. 1261

At: Novo Nordisk A/S

Novo Allé 1

2880 Bagsvaerd

Denmark

© 2025 Novo Nordisk

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Alhemo (concizumab-mtci) injection is a clear to slightly opalescent, colorless to slightly yellow liquid, that may contain translucent to white particles. Alhemo is available as one single-patient-use prefilled pen per carton in the following presentations (seeTable 3):

Table 3. Alhemo Presentations

Storage and Handling

Before first use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze.

After first use: Store in a refrigerator at 36℉ to 46˚F (2℃ to 8˚C) or at room temperature below 86˚F (30˚C) for up to 28 days. Write the date of first use in the space provided on the carton. Discard the unused portion of the pen 28 days after first opening.

Store Alhemo with the cap on and in the original carton to protect from light. Alhemo should not be stored in direct sunlight, and the Alhemo pen should be kept away from direct heat. Do not freeze or store it close to a cooling element in a refrigerator (the part that cools the refrigerator). Do not use Alhemo if it has been frozen or stored at temperatures above 86˚F (30˚C).

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INSTRUCTIONS FOR USE SECTION

Instructions for Use – 3.0 mL (300 mg)

INSTRUCTIONS FOR USE

Alhemo**®**** (al-HEE-mo)**

(concizumab-mtci)

injection, for subcutaneous use

300 mg/3 mL (100 mg/mL) single-patient-use prefilled pen

This Instructions for Use contains information on how to inject Alhemo. Read and understand these instructions before you use the Alhemo pen. Make sure you have received training from your healthcare provider before you inject with this pen for the first time.

Gather the following supplies:

•

1 Alhemo pen

Supplies you will need that are not included in the carton:

•

a new needle for each injection. The Alhemo pen is recommended to be used with NovoFine® and NovoFine® Plus needles with a gauge of 32 and length of 4mm (32G x 4 mm).

•

sharps disposal container. See** “Throwing away (disposing of) Alhemo pens, needles and needle caps.”**

•

alcohol swab

•

Take your dose as prescribed by your healthcare provider. 

•

Alhemo is supplied as a prefilled pen (called “Alhemo pen” or “pen” in these instructions). It contains 300 milligrams (mg) of Alhemo for subcutaneous injection. The pen contains multiple doses of Alhemo.

•

The pen can deliver a maximum of 80 mg in 1 injection. The interval on the dose counter is 1 mg. If you need more than 80 mg, you need to inject multiple times. Your healthcare provider will tell you how much Alhemo to inject.

Where on my body should I inject my dose?

•

You can inject into the skin of:

o

your stomach-area (abdomen) at least 2 inches from your belly button (navel) 
**or**

o

your upper legs (thigh).

•

The gray areas on the picture to the right show the injection sites. 

•

Change (rotate) your injection site with each injection every day.**Do not** use the same site for each injection. 

•

**Do not** inject into skin that is tender, bruised, red or hard, or areas where there are moles, scars, or stretch marks.

1. Check your Alhemo pen

•

**Wash your hands with soap and water**
Dry them well.

•

**Check the pen label**
Check the name, strength, and colored label to make sure you have the right medicine.

•

**Check the expiration date**
Check the expiration date (EXP) on the pen label to make sure it has not passed (YYYY-MM-DD). If the expiration date has passed, do not use the pen.

•

**Inspect the medicine**
Pull off the pen cap and check that Alhemo in the pen window is almost clear and colorless to slightly yellow. The medicine may contain particles that you can see-through or are white.**Do not**use the pen if the medicine is discolored.

•

**If your pen is cold**
You can inject Alhemo right from the refrigerator or let it reach room temperature before you inject. You can warm the pen in the palms of your hands. Do not use any other heating sources.

2. Attach a new needle

•

Take a new needle and tear off the paper tab. 

•

Push the needle straight onto your pen. Turn the needle clockwise until it is 
on tight. See**Figure A**.

•

Pull off the outer needle cap. See**Figure B**.

•

Pull off the inner needle cap.See**Figure B**.

•

Throw the needle caps away in an FDA-cleared sharps disposal container.

Note: Always use a new needle for each injection.

3. Prime before each dose. Dial to ‘1’ and test the flow before each dose

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•

A drop of Alhemo may appear at the needle tip, but you should still test the Alhemo flow before**each injection** to make sure you get the correct dose of Alhemo:

o

Turn the dose selector one marking to select 1 mg. See**Figure C**.

o

Press the dose button. See**Figure D**.

o

Watch a stream of Alhemo leaving the needle tip. See**Figure D**.

•

If no stream appears, go to**“Troubleshooting if no stream appears when testing the flow.”**

4. Select your dose

•

Turn the dose selector to select your prescribed dose.

•

You can adjust your dose by turning the dose selector in either direction (forwards or backwards).

•

If you need a larger dose than you can dial, you must inject yourself multiple times to get your full dose. For more information, see**Step 6**. 

•

Each pen contains 300 mg of Alhemo.

•

The pen can deliver doses from 1 mg to 80 mg in 1 injection.

5a. Prepare the injection site

Read throughSteps 5a and 5b before you start injecting. This is to make sure you get your full dose.

•

Select the injection site. See “**Where on my body should I inject my dose?”**

•

Wipe the injection site with an alcohol swab and let the area dry. Do not touch the injection site after cleaning.

•

Insert the needle straight into your stomach-area (abdomen) or upper legs (thigh) at a 90-degree angle, as instructed by your healthcare provider.

5b. Inject Alhemo

•

Press and hold the dose button down until the dose counter returns to**“0”**. 

•

Once the dose counter has returned to “**0**”,** count slowly to 6 while the needle is still in your skin.**

•

Remove the needle from your skin.

The pen clicks during the injection and you might also hear or feel a click when the dose counter returns to “0”.

6. Remove the needle

•

Carefully remove the needle from your pen by turning the needle counterclockwise. Do not touch the pen needle on either side to avoid sticking yourself with the needle. 

•

Place the needle in an FDA-cleared sharps disposal container right away to reduce the risk of a needle stick. See**“Throwing away (disposing of) Alhemo pens, needles and needle caps.”**

•

**Do not**put the needle cap back on. 

Do you need a larger dose than you can dial?

RepeatSteps 1 to** 6until you have received your full dose. When you have received your full dose go toStep 7**.

•

Use a new needle for each injection.

•

Test the Alhemo flow before each injection.

•

Make sure you know how much to inject in each injection to receive your full dose. 
**Note:** Only split your dose if you have been trained or told by your healthcare provider on how to do this.

7. Recap the pen

•

Put the pen cap back on your pen to protect Alhemo from light. 

•

Now your pen is ready for storage until you need it next time. See**“Storing Alhemo.”**

** Important information you need to know before injecting Alhemo**

•

Use Alhemo exactly as prescribed by your healthcare provider.

•

Your Alhemo pen is for single-patient-use only. Do not share your Alhemo pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.

•

Your healthcare provider should show you or your caregiver how to use Alhemo before you use it for the first time. 

•

Ask your healthcare provider if you need to use a different injection technique. For example, children and people who are lean may need to inject into a pinched fold of skin to avoid injecting too deep (into the muscle).

•

After 28 days, you must throw away (discard) your pen in an FDA-cleared sharps disposal container even if some medicine is left in the pen. 

•

The pen can deliver doses from 1 mg to 80 mg in 1 injection. If your dose is more than 80 mg, you need to inject multiple times.

Important information about needles

•

Needles can be used for 1 injection only. Always use a new needle for each injection. 

•

Do not reuse needles as this reduces the risk of contamination, infection, leakage, blocked needles, and incorrect dosing.

•

Never share needles with others. 

•

Alhemo is recommended to be used with NovoFine and NovoFine Plus 32G x 4 mm injection needles. 

•

If you use needles longer than 4 mm, talk to your healthcare provider about how to perform your injection.

•

Talk to your healthcare provider or pharmacist for more information about needles for your Alhemo pen.

•

Do not use the needle if it is bent or damaged.

Troubleshooting if no stream appears when testing the flow (Step 3)

•

If no stream appears, repeat**Step 3** up to 6 times until you see a stream.

•

If still no stream appears, prepare a new needle (**Step 2**) and test again (**Step 3**). 

•

If still no stream appears after attaching a new needle, do not use the pen. Use a new pen or call Novo Nordisk at 1-844-668-6732 for help.

How much Alhemo is left in your pen?

The pen scale shows about how much Alhemo is left in your pen. In the example below, 200 milligrams (mg) is remaining in the pen.

If you want to see more accurately how much Alhemo is left in your pen, turn the dose selector until it stops. The dose pointer will line up with the number of mg left in the pen.

If the dose counter shows 80 mg, at least 80 mg is left in the pen. If the dose counter shows less than 80 mg, the number shown in the dose counter is the number of mg left in the pen. In the example below, the dose counter shows 34 mg, so there is 34 mg of Alhemo left in the pen.

Storing Alhemo

•

**Before first use:**

o

Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C). 

•

**After first use:**

o

Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature no warmer than 86°F (30°C) for up to 28 days.

o

Write the date of first use in the space provided on the carton. 

o

Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen.

•

Store Alhemo with the cap on and keep it in the original carton to protect from light.

•

Do not store Alhemo in direct sunlight and keep away from direct heat.

•

When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator).

•

Do not freeze Alhemo. 

•

Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C).

Keep Alhemo and all medicine out of the reach of children.

Throwing away (disposing of) Alhemo pens, needles, needle caps

•

Put your used pens, needles, and needle caps in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and pens in your household trash. 

•

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: 

o

made of heavy-duty plastic,

o

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, 

o

upright and stable during use,

o

leak-resistant, and

o

properly labeled to warn of hazardous waste inside the container.

•

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should dispose of used needles and pens. For more information about safe sharps disposal, and for specific information about safe sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

•

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Scan the QR code below to access the Instructions for Use or visit: www.Alhemopen.com

Patent Information: http://novonordisk-us.com/products/product- patents.html

Alhemo® is a registered trademark of Novo Nordisk Health Care AG.

NovoFine®, NovoFine® Plus, and Novo Nordisk® are registered trademarks of Novo Nordisk A/S.

© 2024 Novo Nordisk Health Care AG

For further information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-844-668-6732

Manufactured by:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

U.S. License No. 1261

At: Novo Nordisk A/S

Novo Allé 1

2880 Bagsvaerd

Denmark

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Issued: 12/2024

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