Bimekizumab-bkzx (subcutaneous)

Bimekizumab-bkzx (subcutaneous)

Bimekizumab-bkzx (subcutaneous)

Uses for bimekizumab-bkzx

This medicine is only available with a doctor's prescription.

Before using bimekizumab-bkzx

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the association between age and the effects of bimekizumab bkzx injection in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Related studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of bimekizumab bkzx injection in the elderly.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Adenovirus-Impfstoff, lebend
• Bacillus of Calmette und Guerin-Impfstoff, lebend
• Cholera-Impfstoff, lebend
• Cyclosporin
• Tetravalenter Dengue-Impfstoff, lebend
• Ebola-Zaire-Impfstoff, lebend
• Influenzavirus-Impfstoff, lebend
• Masernvirus-Impfstoff, lebend
• Mumpsvirus-Impfstoff, lebend
• Poliovirus-Impfstoff, lebend
• Rotavirus-Impfstoff, lebend
• Rötelnvirus-Impfstoff, lebend
• Pocken-Affenpocken-Impfstoff, lebend, nicht replizierend
• Pockenimpfstoff
• Typhus-Impfstoff, lebend
• Varizellenvirus-Impfstoff, lebend
• Warfarin
• Gelbfieber-Impfstoff
• Zoster-Impfstoff, lebend

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Depression, Geschichte von oder
• Infektion, Geschichte von oder
• Entzündliche Darmerkrankung (z. B. Morbus Crohn oder Colitis ulcerosa), aktive oder
• Lebererkrankung bzw
• Selbstmordgedanken oder -verhalten, Vorgeschichte von – Mit Vorsicht verwenden. Kann diese Bedingungen verschlimmern.

• Infektion, aktiv – Die Anwendung wird bei Patienten mit dieser Erkrankung nicht empfohlen.

• Tuberkulose, inaktiv – sollte vor der Einnahme dieses Arzneimittels behandelt werden.

Proper use of bimekizumab-bkzx

This medicine is given as an injection under the skin of your thigh, stomach, or upper arm. It can be administered at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will show you how to prepare and inject the medicine. Make sure you understand how to use this medicine.

This medication includes a medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You will be shown the areas of the body where this recording can be carried out. Use a different area of ​​the body each time you get a shot. Keep track of where you fire each shot to make sure you switch body areas. Do not inject into areas of skin that are bruised, red, hard, tender, thick, scaly, or have psoriasis.

This medicine comes in two forms: an auto-injector and a pre-filled syringe. Your doctor will tell you which dosage form to use.

Wait 30 to 45 minutes for the autoinjector or prefilled syringe to warm to room temperature. Do not heat with heat sources (e.g. hot water, microwave or sunlight).

Check the fluid in the autoinjector or prefilled syringe. It should be clear to slightly pearly and colorless to pale brownish-yellow. Do not use the medicine if it is cloudy, discolored, or contains particles. Do not use the autoinjector or prefilled syringe if it looks damaged or has been dropped. Don't shake.

How to use the autoinjector:

• Waschen Sie Ihre Hände vor und nach der Anwendung dieses Arzneimittels mit Wasser und Seife.
• Entfernen Sie die Autoinjektorkappe. Halten Sie den Autoinjektor mit einer Hand am Griff fest. Ziehen Sie die Kappe mit der anderen Hand gerade ab.
• Berühren Sie nicht den Nadelschutz oder die Rückkappe.
• Halten Sie den Autoinjektor in einem 90-Grad-Winkel. Platzieren Sie den Autoinjektor flach auf Ihrer Haut und drücken Sie ihn dann fest auf Ihre Haut. Sie hören ein „Klick“-Geräusch. Ihre Injektion beginnt, wenn Sie das erste Klicken hören. Heben Sie den Autoinjektor nicht von der Haut ab.
• Halten Sie den Autoinjektor weiterhin fest, während Sie ihn fest gegen Ihre Haut drücken. Es dauert etwa 15 Sekunden, bis Sie Ihre volle Dosis erhalten. Etwa 15 Sekunden nach dem ersten Klicken hören Sie ein zweites Klicken.
• Der zweite Klick zeigt an, dass das gesamte Arzneimittel injiziert wurde. Sie sollten sehen, dass die gelbe Farbanzeige das Sichtfenster ausfüllt. Wenn das Fenster nicht gelb wird, bedeutet dies, dass Sie möglicherweise nicht die volle Dosis erhalten haben.
• Entfernen Sie den Autoinjektor, indem Sie ihn gerade nach oben von Ihrer Haut abziehen. Berühren Sie nicht die Nadel.

How to use the pre-filled syringe:

• Waschen Sie Ihre Hände vor und nach der Anwendung dieses Arzneimittels mit Wasser und Seife.
• Entfernen Sie die Nadelkappe. Halten Sie die Spritze mit einer Hand um den Fingergriff und ziehen Sie mit der anderen Hand die Nadelkappe gerade ab. Berühren Sie die Nadel nicht und verschließen Sie sie nicht.
• Drücken Sie eine Hautfalte vorsichtig zusammen und halten Sie sie fest. Führen Sie mit der anderen Hand die Nadel in einem Winkel von etwa 45 Grad in Ihre Haut ein.
• Drücken Sie den Kolbenkopf ganz nach unten, bis das gesamte Arzneimittel injiziert ist.
• Heben Sie Ihren Daumen vom Kolbenkopf ab. Die Nadel bewegt sich zurück und rastet ein.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für Injektionsdosierungsformen (Fertigspritze oder Autoinjektor):
  • Bei Plaque-Psoriasis:
    • Erwachsene – 320 Milligramm (mg), injiziert unter die Haut, verabreicht in zwei Spritzen (jeweils 160 mg) in den Wochen 0, 4, 8, 12 und 16, danach alle 8 Wochen.
    • Kinder – Anwendung und Dosis müssen von Ihrem Arzt festgelegt werden.

Missed dose

Call your doctor or pharmacist for instructions.

If you miss a dose, inject it as soon as possible. Then inject the next dose at the next scheduled time.

storage

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Store in the refrigerator. Do not freeze.

You can store this medicine at room temperature for up to 30 days. Do not put it back in the refrigerator. Discard any unused medicine after 30 days.

Discard used autoinjectors and syringes in a sturdy, closed container that the needles cannot puncture. Keep this container away from children and pets.

Precautions when using bimekizumab-bkzx

It is very important that the doctor checks your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for adverse effects.

This medicine may make some people feel restless, irritable, or exhibit other abnormal behavior. It can also cause some people to have suicidal thoughts and tendencies or become more depressed. Also tell your doctor if you experience any sudden or strong feelings, including nervousness, anger, restlessness, violence, or fear. If you or your caregiver notice any of these side effects, tell your doctor immediately.

Before you start using this medicine, a skin test for tuberculosis must be done. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infections may be reduced during treatment with bimekizumab-bkzx. It is very important that you call your doctor at the first sign of infection. Consult your doctor immediately if you experience any of the following symptoms while using this medication: fever, chills, cough or hoarseness, flu-like symptoms, pain in the lower back or sides, painful or difficult urination, or unusual tiredness or weakness.

Contact your doctor immediately if you have pain or tenderness in your upper abdomen, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of serious liver disease.

Inflammatory bowel disease may occur while using this medication. Tell your doctor right away if you have rectal bleeding, severe stomach pain, or severe diarrhea while using this medication.

Do not get vaccinated during treatment with bimekizumab-bkzx or after treatment has stopped without your doctor's approval. Bimekizumab-bkzx can reduce your body's resistance and the vaccine may not work as well or you may get the infection that the vaccine is intended to prevent. In addition, you should not be near others in your household who are receiving live virus vaccines, as there is a risk that they may transmit the virus to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Don't get too close to them or stay in the same room with them for too long. If you have any questions about this, talk to your doctor.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medications and herbal or vitamin supplements.

Bimekizumab-bkzx side effects

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

More common

• Körperschmerzen oder Schmerzen
• Engegefühl in der Brust
• Schüttelfrost
• Husten
• Trockenheit oder Schmerzen im Hals
• verstopfte Ohren
• Fieber
• Kopfschmerzen
• Heiserkeit
• Verlust der Stimme
• Muskelkater
• Schmerzen oder Druckempfindlichkeit um Augen und Wangenknochen
• niesen
• wunder Mund oder Zunge
• verstopfte oder laufende Nase
• empfindliche, geschwollene Drüsen im Nacken
• Atembeschwerden
• Schwierigkeiten beim Schlucken
• ungewöhnliche Müdigkeit oder Schwäche
• weiße Flecken im Mund oder auf der Zunge

Less common

• Brennen oder Stechen der Haut
• Durchfall
• Juckreiz im Genitalbereich oder anderen Hautbereichen
• Juckreiz der Vagina oder Genitalien
• Appetitverlust
• Brechreiz
• schmerzhafte Fieberbläschen oder Blasen an Lippen, Nase, Augen oder Genitalien
• Skalierung
• Magenschmerzen
• dicker, weißer Vaginalausfluss mit mildem oder keinem Geruch

Incident not known

• Verhaltensänderungen
• dunkler Urin
• rektale Blutung
• Gedanken daran, sich umzubringen
• Erbrechen
• gelbe Augen oder Haut

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Less common

• Blutungen, Blasenbildung, Brennen, Kälte, Verfärbung der Haut, Druckgefühl, Nesselsucht, Infektion, Entzündung, Juckreiz, Knoten, Taubheitsgefühl, Schmerzen, Hautausschlag, Rötung, Narbenbildung, Schmerzen, Stechen, Schwellung, Empfindlichkeit, Kribbeln, Geschwüre oder Wärme an der Injektionsstelle
• Hautunreinheiten
• Brennen, Juckreiz und Schmerzen in den behaarten Bereichen, Eiter an der Haarwurzel
• Pickel

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Bimzelx

Available dosage forms:

• Lösung

Therapeutic class: Antipsoriatics

Pharmacological class: Bimekizumab

More information