Humalog Junior KwikPen 100 units/ml solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Humalog KwikPen 100 units/ml solution for injection in a pre-filled pen

insulin lispro

Each KwikPen delivers 1 to 60 units in 1-unit increments.

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 or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Humalog KwikPen is and what it is used for
2. What you need to know before you use Humalog KwikPen
3. How to use Humalog KwikPen
4. Possible side effects
5. How to store Humalog KwikPen
6. Contents of the pack and other information

1. What Humalog KwikPen is and what it is used for

Humalog KwikPen is used to treat diabetes. It works more quickly than regular human insulin because the insulin molecule has been slightly modified.

You have diabetes when your pancreas does not produce enough insulin to control your blood glucose levels. Humalog is a replacement for your own insulin and is used to control glucose levels over the long term. It acts very rapidly and for a shorter duration than soluble insulin (2 to 5 hours). Humalog is usually taken within 15 minutes around mealtime.

Your doctor may recommend that you use Humalog KwikPen in addition to a longer-acting insulin. Each of these comes with its own patient information leaflet containing specific information. Do not change your insulin unless your doctor tells you to do so. Exercise great caution when switching from one insulin to another.

Humalog is suitable for use in adults and children.

The KwikPen is a disposable, pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro. One KwikPen contains multiple insulin doses. The KwikPen increments by 1 unit. The number of units is displayed in the dose window; always check it before your injection. You may inject from 1 to 60 units in a single injection. If your dose is greater than 60 units, you will need to administer more than one injection.

2. What you need to know before using Humalog KwikPen

DO NOT use Humalog KwikPen

• If you think you are experiencing hypoglycaemia (low blood sugar). How to manage mild hypoglycaemia is explained later in this leaflet (see Section 3: If you use more Humalog than you should).
• If you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• Always check at the pharmacy the name and type of insulin shown on the packaging and label of the pre-filled pen. Make sure you take home the Humalog KwikPen prescribed by your doctor.
• If your blood sugar levels are well controlled with your current insulin therapy, you may not notice the warning symptoms that alert you to low blood sugar. These warning symptoms are described later in this leaflet. You must carefully plan your meal times, exercise schedule, and the extent of physical activity. You must also monitor your blood sugar levels closely by frequently testing your blood glucose.
• Some patients who experienced hypoglycaemia after switching from animal insulin to human insulin have reported that early warning symptoms were less noticeable or different. If you frequently experience hypoglycaemia or have difficulty recognizing it, please inform your doctor.
• If you answer YES to any of the following questions, discuss it with your doctor, pharmacist, or diabetes educator:
  • Have you recently become ill?
  • Do you have liver or kidney problems?
  • Are you exercising more than usual?
• The amount of insulin you need may change if you consume alcohol.
• If you are planning to travel abroad, inform your doctor, pharmacist, or diabetes educator. Time differences between countries may require you to follow a different schedule for injections and meals than the one you follow at home.
• Some patients with long-standing type 2 diabetes and a history of heart disease or stroke who were treated with pioglitazone and insulin developed heart failure.

Inform your doctor as soon as possible if you experience signs of heart failure such as difficulty breathing, rapid weight gain, or localized swelling (edema).

• It is not recommended that blind individuals or people with visual impairments use this pen without the assistance of a person trained in the use of the pen.

Skin changes at the injection site

You should rotate your injection sites to avoid skin changes such as lumps under the skin. Insulin may not work as effectively if injected into a lumpy area (see How to use Humalog KwikPen). Contact your doctor if you are currently injecting into a lumpy area before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and adjust your insulin dose or that of your other antidiabetic medications.

Other medicines and Humalog KwikPen

Your insulin requirements may change if you are using:

• contraceptives,
• steroids,
• thyroid hormone replacement therapy,
• oral hypoglycaemics,
• acetylsalicylic acid,
• sulfa antibiotics,
• octreotide,
• beta2 stimulants (e.g. ritodrine, salbutamol, or terbutaline),
• beta-blockers, or
• certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
• danazol,
• certain angiotensin-converting enzyme inhibitors (e.g. captopril, enalapril), and
• angiotensin II receptor blockers.

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription (see section “Warnings and precautions”).

Pregnancy and breastfeeding

Are you pregnant or planning to become pregnant? Are you breastfeeding? The amount of insulin you need usually decreases during the first three months of pregnancy and increases during the following six months. If you are breastfeeding, you may need to adjust your insulin dose or diet. If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Your ability to concentrate or react may be reduced if you experience hypoglycaemia. Be aware of this potential problem and consider all situations that could pose a risk to yourself or others (e.g., driving a vehicle or operating machinery). You should consult your doctor about whether it is safe for you to drive if you:

• have frequent episodes of hypoglycaemia
• have difficulty perceiving or do not perceive symptoms of hypoglycaemia

Humalog KwikPen contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; essentially, it is “sodium-free”.

3. How to use Humalog KwikPen

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor again. To prevent the possible transmission of disease, each pen must be used only by you, even if the needle is changed.

Dosage

• Humalog should normally be injected within 15 minutes around mealtime. If necessary, you may inject it shortly after a meal. However, your doctor will have told you exactly how much to use, when to take it, and how often. These instructions are specific to you. Follow them precisely and attend your diabetes clinic regularly.
• If you change the type of insulin you use (for example, from animal or human insulin to a product containing Humalog), you may need to use a different amount than before. This may apply only for the first injection or may require a gradual adjustment lasting several weeks or months.
• Humalog KwikPen is intended only for subcutaneous injection. Consult your doctor if you need to administer insulin by another method.

How to prepare Humalog KwikPen

• Humalog is already dissolved in water, so it does not need to be mixed. However, only use it if it appears like water—clear, colorless, and free of solid particles. Check this before each injection.

How to prepare the KwikPen (please read the user manual)

• First, wash your hands.
• Read the instructions on how to use your pre-filled insulin pen. Follow the instructions carefully. The following are some reminders.
• Use a new needle. (Needles are not included.)
• Prime your KwikPen before each use. This ensures insulin flows properly and removes air bubbles from the pen. Small air bubbles may still remain in the pen; these are harmless. However, if the air bubble is too large, the injected dose may be less accurate.

How to inject Humalog

• Before injecting, clean the skin as you have been taught. Inject under the skin as instructed. Do not inject directly into a vein. After the injection, leave the needle in the skin for five seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure to inject at least 1 cm away from your last injection site and rotate injection sites as instructed. Humalog will always act faster than soluble human insulin, regardless of the injection site (upper arms, thighs, buttocks, or abdomen).
• Humalog must not be administered intravenously. Inject Humalog as taught by your doctor or diabetes educator. Only your doctor may administer Humalog intravenously, and only under special circumstances such as surgery or if you are ill and your glucose levels are too high.

After injection

• Immediately after injecting, unscrew the needle from the KwikPen using the outer needle cap. This keeps the insulin sterile and prevents leakage. It also prevents air from entering the pen and avoids needle blockage. Do not share needles. Do not share your pen. Replace the cap on the pen.

Subsequent injections

• Each time you use the KwikPen, use a new needle. Before each injection, remove all air bubbles. You can see the remaining insulin by holding the KwikPen with the needle pointing upward. The scale on the cartridge shows approximately how many units remain.
• Do not mix any other insulin into the disposable pen. When the KwikPen is empty, it cannot be reused. Dispose of the pen responsibly; your pharmacist or diabetes educator will advise you how to do this.

Use of Humalog in an insulin infusion pump

• Humalog KwikPen is intended only for subcutaneous injection. Do not use the pen for administration by any other route. If another method is required, other presentations of Humalog 100 units/mL are available. Consult your doctor if you need to administer insulin by another method.

If you use more Humalog than you should

If you use more Humalog than needed or are unsure how much you have injected, you may experience low blood sugar. Check your blood glucose.

If your blood sugar is low (mild hypoglycemia), take glucose tablets, sugar, or a sugary drink. Then eat fruit, biscuits, or a snack as instructed by your doctor, and rest. This usually resolves mild hypoglycemia or a small insulin overdose. If symptoms worsen and your breathing becomes shallow and your skin turns pale, call your doctor immediately. Severe hypoglycemia can be treated with a glucagon injection. After a glucagon injection, glucose or sugar must be taken. If there is no response to glucagon, go to the hospital. Ask your doctor for information about glucagon.

If you forget to use Humalog

If you use less Humalog than needed or are unsure how much you have injected, you may experience high blood sugar. Check your blood glucose.

If not treated properly, hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) can become very serious and cause headache, nausea, vomiting, dehydration, loss of consciousness, coma, and even death (see A and B in section 4 “Possible side effects”).

Three simple measures to avoid hypoglycemia or hyperglycemia are:

• Always keep spare syringes and vials of Humalog, or extra pens and cartridges, in case you lose your KwikPen or it becomes damaged.
• Always carry some form of identification indicating you have diabetes.
• Always carry a source of sugar with you.

If you stop using Humalog

If you use less Humalog than needed, you may experience high blood sugar. Do not switch insulin types unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Systemic allergy is rare (≥1/10,000 to <1/1,000). It presents the following symptoms:

If you think you are experiencing this type of allergy with Humalog, speak to your doctor immediately.

Local allergy is common (≥ 1/100 to <1/10). In some people, the area where insulin has been injected becomes red, swollen, or itchy. This condition usually resolves within a few days or weeks. If this occurs, inform your doctor.

Lipodystrophy is uncommon (≥ 1/1,000 to <1/100). If you inject insulin too frequently in the same spot, the fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy). Lumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis). Insulin may not work as well if injected into an area with lumps. Change your injection site regularly to help prevent these skin changes.

Cases of edema (for example, swelling in the arms, ankles; fluid retention) have been reported, particularly at the beginning of insulin treatment or during changes in treatment aimed at improving blood sugar control.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

Common diabetes-related problems

1. Hypoglycemia

Hypoglycemia (low blood sugar level) means you have too little sugar in your blood. It can be caused by:

• administering too much Humalog or any other type of insulin;
• skipping a meal, delaying a meal, or changing your diet;
• exerting excessive physical effort or exercising too much just before or after a meal;
• having an infection or being ill (especially diarrhea or vomiting);
• changes in your insulin requirements; or
• worsening of kidney or liver disease.

Alcohol and certain medications can affect your blood sugar levels.

The first symptoms of low blood sugar usually appear suddenly and include:

Until you are certain you recognize the warning symptoms, avoid situations (e.g., driving a car) in which you or others might be put at risk if hypoglycemia occurs.

1. Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (too much sugar in the blood) means the body does not have enough insulin. Hyperglycemia may be caused by:

• not having taken Humalog or any other type of insulin;
• having taken less insulin than prescribed by your doctor;
• having eaten much more than your diet allows; or
• having a fever, infection, or emotional stress.

Hyperglycemia may progress to diabetic ketoacidosis. The initial symptoms develop slowly, over several hours or days. These symptoms include:

Severe symptoms are labored breathing and rapid pulse. Seek immediate medical assistance.

1. Illnesses

If you are ill, especially if you have nausea or vomiting, the amount of insulin you need may vary. Even if you are not eating as usual, you still need to take insulin. Test your urine or blood, follow the instructions you have been given for when you are ill, and contact your doctor.

5. Storage of Humalog KwikPen

Before first use, store Humalog KwikPen in the refrigerator (between 2°C and 8°C). Do not freeze.

Keep your in-use Humalog KwikPen at room temperature (below 30°C) and discard it after 28 days. Do not place it near heat sources or expose it to direct sunlight. Do not store the KwikPen you are currently using in the refrigerator. Never store the KwikPen with the needle attached.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and packaging. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice it has changed colour or contains solid particles. Use it only if it appears clear like water. Check this before each injection.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Humalog KwikPen 100 units/ml solution for injection

• The active substance is insulin lispro. Insulin lispro is produced in the laboratory by a "recombinant DNA technology" process. It is a modified form of human insulin and therefore differs from other human insulins and from animal-source insulins. Insulin lispro is closely related to human insulin, which is a natural hormone produced by the pancreas.
• The other components are m-cresol, glycerol, dibasic sodium phosphate·7H2O, zinc oxide, and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the pH.

Nature of the product and contents of the pack

Humalog KwikPen 100 units/ml solution for injection is a sterile, clear, colourless, aqueous solution containing 100 units of insulin lispro per millilitre of injectable solution (100 units/ml). Each Humalog KwikPen contains 300 units (3 millilitres). Humalog KwikPen is available in packs of 5 pre-filled pens or in multiple packs consisting of 2 packs of 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog 100 units/ml contained in your pre-filled pen is identical to the Humalog 100 units/ml available in individual cartridges of Humalog 100 units/ml. The KwikPen device simply contains a cartridge inside. When the pre-filled pen is empty, it cannot be reused.

Marketing Authorization Holder and Manufacturer

Humalog KwikPen 100 units/ml solution for injection is manufactured by:

• Lilly France, S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,
• Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy.

The Marketing Authorization Holder is Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, the Netherlands.

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

USER MANUAL

The user manual text is included at the end.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.