Remsima 100mg Injection 1 vial

Description

About

Remsima 100mg Injection 1 vial belongs to a class of drugs called, Tumor Necrosis Factor inhibitors (TNF) or Monoclonal antibodies used to treat immune-related conditions like Crohn’s Disease, Ulcerative Colitis, inflammatory bowel disease, rheumatoid arthritis, ankylosing Spondylitis, psoriasis, and other conditions. Remsima 100mg Injection 1 vial utilizes synthetic antibodies (monoclonal antibodies) contained in it to offer a targeted treatment of certain immune factors causing the inflammatory disease. This may be used alone or alongside other medicines to help you overcome your illness.  

Remsima 100mg Injection 1 vial is chemically composed of Infliximab, which binds to and blocks the function of naturally occurring proteins called Tumor Necrosis Factor – α,  a key mediator of inflammation in the body. This inhibition causes a decrease in the activity of other inflammatory proteins like interleukins, thereby reducing the inflammation. The full effects start to become evident clinically slowly, about 2 weeks after the first infusion. Remsima 100mg Injection 1 vial is injected every few weeks commonly between 2 to 8 weeks during your therapy. 

Remsima 100mg Injection 1 vial is available on prescription, in powder form to be injected after proper transformation into an infusion solution given slowly in a hospital. Dosage of Remsima 100mg Injection 1 vial depends on age, the severity of the condition, patients’ response to the medicine, and any other drugs being taken. Remsima 100mg Injection 1 vial can be prescribed to both children 6 years and above and adults alike. It is not recommended for pregnant females and breastfeeding mothers without a doctor’s advice. Common side effects of this medication include pain at the injection site, nausea, vomiting, respiratory tract infections, risk of infections, skin rash, and chest pain, among others. 

Indications

Remsima 100mg Injection 1 vial can be used to treat:

• Crohn’s Disease
• Ulcerative Colitis
• Inflammatory bowel disease
• Rheumatoid arthritis
• Ankylosing Spondylitis
• Psoriasis
• Psoriatic arthritis 

How does Remsima 100mg Injection 1 vial work

Remsima 100mg Injection 1 vial is chemically composed of Infliximab, which binds to and blocks the function of naturally occurring proteins called Tumor Necrosis Factor – α,  a key mediator of inflammation in the body. This inhibition causes a decrease in the activity of other inflammatory proteins like interleukins, thereby reducing the inflammation in the body due to your disease. 

How to use Remsima 100mg Injection 1 vial

Remsima 100mg Injection 1 vial comes packed in a glass container with a dry powder to be injected after proper transformation into an infusion solution. The dry powder contains a concentrated form of Infliximab that has to be diluted with other injectable solutions matching the compatibility with Remsima 100mg Injection 1 vial such as sodium chloride solution. It is given intravenously as a slow infusion over 1 to 2 hours. The dosage depends upon the severity of the inflammation, and kidney and liver function. Remsima 100mg Injection 1 vial must not be used without a doctor’s advice to avoid serious consequences. Remsima 100mg Injection 1 vial is administered in a hospital under a doctor’s supervision. You will be recalled to the hospital every few weeks, usually between 2 to 8 weeks depending on your symptoms. It is a daytime procedure, and you will be discharged after an observation period of approximately 2 hours at the end of your therapy session. IV infliximab can also be administered at home. A healthcare provider or a visiting nurse can be appointed to help you maintain an IV line at home. Always start by cleaning your hands and the area to be injected. Carefully first check the glass vials to rule out any contaminant in the solution. Read the label carefully to know the exact ratio before reassembling the contents into a solution form.  A new, sterile syringe must always be used and properly discarded following universal protocol for sharps disposal.

Available Potency and form of Remsima 100mg Injection 1 vial 

• 100 mg   – Dry powder for injection

Dosage

Adult Dose

Ulcerative Colitis 

5 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 8 weeks afterward 

Crohn’s Disease

5 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 8 weeks afterward 

The dose may be increased up to 10 mg/kg in case the clinical response is not being recorded in patients who have become tolerant to Remsima 100mg Injection 1 vial 

Ankylosing Spondylitis

5 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 6 weeks afterward 

Rheumatoid arthritis

3 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 8 weeks afterward 

The dose may be increased up to 10 mg/kg in case the clinical response is not being recorded in patients who have become tolerant to {{product}. Alternatively, an infusion can be repeated sooner than usual, such as at every 4 weeks interval

Psoriatic arthritis and plaque psoriasis

5 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 8 weeks afterward 

It May be given in combination with methotrexate, an anti-rheumatic drug

Child Dose

Remsima 100mg Injection 1 vial is not considered safe for children 6 years of age and above. Make sure your child is fully immunized before starting Remsima 100mg Injection 1 vial and do not receive any live vaccines during the therapy since it increases the risk of infections.

Crohn’s Disease

Less than 6 years: Inadequate safety data

6 to 17 years: 5 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 8 weeks afterward 

Ulcerative Colitis 

Less than 6 years: Inadequate safety data

More than 6 years: 5 mg/kg to be infused intravenously at an interval of a few weeks scheduled as  0, 2, and 6 weeks, then every 8 weeks afterward 

Pregnancy use and lactation

Remsima 100mg Injection 1 vial is classified as a Pregnancy category B drug by FDA (meaning no evidence of any risk to the fetus in controlled animal trials but insufficient data is available in humans). If you are pregnant, think you may be pregnant, or are planning to have a baby, please consult your doctor before using Remsima 100mg Injection 1 vial.

Remsima 100mg Injection 1 vial is also secreted in human milk, if you are breastfeeding, please consult your doctor before taking Remsima 100mg Injection 1 vial. 

Contraindications

Please inform your doctor if you have a history of any of these before using Remsima 100mg Injection 1 vial:

• Allergic reaction to Remsima 100mg Injection 1 vial
• Mild to moderate heart failure
• Pre-existing/current severe infections like sepsis or pneumonia, etc.
• Tuberculosis 
• Pulmonary fibrosis or severe lung condition 
• Children less than 6 years of age

Precautions

Please tell your doctor about any of the following conditions before using Remsima 100mg Injection 1 vial:

• Remsima 100mg Injection 1 vial must be used with caution if you have a history of drug-related allergies
• Care must be exercised if you have a history of heart conditions that can get aggravated. In cases of heart failure, this drug should not be used
• The patient is at risk of developing infections during the therapy. Watch out for signs of severe infection and practice vigilance and avoid staying near people carrying infections to avoid infections
• While having treatment with Remsima 100mg Injection 1 vial  and sometime after your therapy ends, do not receive any live vaccines like MMR, BCG, shingles, etc.
• Remsima 100mg Injection 1 vial should not be taken during pregnancy. Discuss with your doctor who will only prescribe it if considered necessary
• If for some reason you have received Remsima 100mg Injection 1 vial during pregnancy. It is suggested that your baby should avoid getting live vaccines for up to 6 months since Remsima 100mg Injection 1 vial can cross the placenta 
• Cautious administration of Remsima 100mg Injection 1 vial is advised if you suffer from seizures
• Cautious administration of Remsima 100mg Injection 1 vial is advised if you suffer from blood or bone marrow disorder
• Cautious administration of Remsima 100mg Injection 1 vial is advised if you have a demyelination condition such as multiple sclerosis

• Remsima 100mg Injection 1 vial carries a risk of reactivation of hepatitis B virus if you have a history. Treatment protocol calls for HBV confirmatory tests before starting the treatment. Monitoring is also required during and after the treatment
• The drug must not be stopped abruptly even if your symptoms have improved since it can produce worsening symptoms upon unplanned discontinuation. Always ask a doctor before stopping 
• A watchful eye on blood cells such as WBCs, platelets, and clotting factors is advised to avoid hemorrhagic conditions and “cytopenias”
• There is a risk of developing cancers with Remsima 100mg Injection 1 vial such as lymphomas, cervical and skin cancer
•  Alcohol on one hand should be taken in moderate amounts, while smoking should be avoided if you have a lung condition to avoid the risk of getting lung cancer

Interaction with other medications

Certain medications could interact with Remsima 100mg Injection 1 vial some of which are enlisted below, hence, inform your doctor about the use of Remsima 100mg Injection 1 vial:

• Anakinra
• Upadacitinib 
• Abatacept
• Azathioprine
• Cyclosporine 
• Etanercept 
• Hydroxychloroquine sulfate 
• Sirolimus 
• Tacrolimus
•  Live vaccines 

Adverse effects

Like most medicines, Remsima 100mg Injection 1 vial has some side effects which include:

Common side effects

• Soreness at the site of injection 
• Headache 
• Nausea 
• Vomiting 
• Increased risk of infections 
• Diarrhea 
• Dizziness 
• Skin rash/itching 
• Palpitations 
• Tiredness 
• Disturbance in total cell count
• Changes in blood pressure 

Less common side effects

• Hypersensitivity/allergic skin reactions; in this case, discontinue 
• Muscle  pain 
• Abdominal cramps
• Aggravation of heart condition 
• Difficulty in breathing 
• Fatigue 
• Malignancies like lymphoma, cervical cancer, etc.
• Edema 
• Swollen lymph nodes 
• Nervous system problems
• Abnormality in complement factor 
• Visual disturbance 
• Immune suppression 
• Emotional disturbance 
• Frequent urination 
• Lupus-like syndrome
• Liver damage

How to cope with some of the adverse effects

• Soreness at the site of injection – A cold compress can be used for 5 minutes to ease the soreness.
• Headaches – In which case make sure you rest and drink plenty of fluids. Avoid the use of alcohol. Take a prescribed painkiller. Consult your doctor if the headaches last longer than a week or are severe
• Feeling or being sick (nausea or vomiting) – Avoid eating rich or spicy food. It might help to take medication after food. If you’re sick, try drinking small, frequent sips of water.
• Diarrhea – Keep yourself hydrated by having lots of fluids and if the problem persists, consult your doctor before taking any medication for vomiting and diarrhea
• Skin Rash – It can be eased by applying soothing and healing lotions or creams such as calamine lotion/cream. Apply a cold compress to the rash helps reduce itchiness and redness caused by the rash. An antihistamine (prescribed by a doctor) is also recommended as an effective way to combat any skin rash.
• Fatigue – Patients experiencing this adverse effect are advised to take deep breaths, intake tea or coffee, get a good night’s rest, and not overburden themselves for a few days.
• Blurred vision – This side effect tends to go away on its own if a few days; patients are advised to not operate heavy machinery or drive any motorized vehicles in the meantime. If blurred vision persists, please contact your doctor.

FAQs

#1. HOW TO STORE Remsima 100mg Injection 1 vial?

Remsima 100mg Injection 1 vial in dry form is to be kept away from the reach of children, in a cool dry place away from direct sunlight and humidity as that tends to ruin certain drugs. After reassembly into solution form, it must be used as soon as possible and can be stored in a refrigerator at 2 to 8 °C for a short time. 

#2. WHAT EXACTLY DOES Remsima 100mg Injection 1 vial DO?

Remsima 100mg Injection 1 vial is used to treat inflammatory conditions of the body like rheumatoid arthritis, ankylosing spondylitis, etc. It blocks the function of naturally occurring proteins called Tumor Necrosis Factor – α,  an essential player of inflammation in the body. 

#3. HOW LONG DOES IT TAKE FOR Remsima 100mg Injection 1 vial TO START WORKING?

The full effects of Remsima 100mg Injection 1 vial may become evident slowly, in about 2 weeks after the first administration.

#4. HOW LONG WILL I HAVE TO TAKE Remsima 100mg Injection 1 vial FOR?

The duration for using Remsima 100mg Injection 1 vial depends on the severity of the condition being treated and your response to the therapy. In general, it is taken at an interval of a couple of weeks for an extended period, follow your doctor’s advice. 

#5. CAN I STOP TAKING  Remsima 100mg Injection 1 vial?

Do not just stop taking the medicine unless advised to do so, make sure to complete your treatment even if you feel better. Stopping it without consulting a doctor will put you at risk of remission of symptoms. 

#6. WHAT IF I FORGET TO TAKE Remsima 100mg Injection 1 vial?

In case you miss a dose, reschedule your appointment for the infusion process.

#7. WHAT IF I TAKE TOO MUCH OF Remsima 100mg Injection 1 vial? 

Remsima 100mg Injection 1 vial is administered by a healthcare professional in a hospital in IV form so it is unlikely to overdose unless mismanaged. If you have accidentally taken an extra amount, contact your doctor immediately. An overdose results in slowing down of heart rate and difficulty breathing accompanied by dizziness and fainting spells.

#8. CAN I TAKE  Remsima 100mg Injection 1 vial DURING PREGNANCY OR BREASTFEEDING?

Discuss the safety of this medicine during pregnancy with your doctor. It is associated with developmental problems in animal trials. If you are pregnant or are planning to conceive a baby, please consult your doctor before using Remsima 100mg Injection 1 vial. If you are breastfeeding, please consult your doctor before taking Remsima 100mg Injection 1 vial as it is secreted in human milk in some amount. 

#9. WILL I HAVE TO UNDERGO ANY TESTS?

You may be required to have regular blood tests and screening particularly at the start of your treatment in form of chest X-rays, viral diagnostic tests like Anti-HBsAg, and others to rule out infections, also these may be conducted at intervals. When you start taking Remsima 100mg Injection 1 vial your doctor would want to monitor your complete blood count (CBC), blood pressure, and kidney function initially and less frequently afterward.

#10. ANY LIFESTYLE CHANGES THAT I NEED TO MAKE?

 Remsima 100mg Injection 1 vial is an immunosuppressant drug which means it is going to increase the likelihood of getting infections. Following measures can be taken to avoid life-threatening infections:

• Maintain a schedule for regular check-ups with your doctor for general health check-ups
• Observe very good overall hygiene, particularly hands must be kept clean
• Wash fruits and vegetables thoroughly before consuming 
• Avoid going out to very crowded public places with the risk of catching infections. Avoid contact with people with a known infection
• Wear a mask when stepping out
• Maintain a healthy diet with prescribed supplements included 
• Avoid alcohol consumption in large amounts and quit smoking

#11. CAN I TAKE ANALGESICS WITH Remsima 100mg Injection 1 vial? 

Yes, you can take NSAID analgesics like paracetamol, ibuprofen, etc. before taking any new medicine always consult a doctor first.

#12. CAN I RECEIVE VACCINES WHILE ON Remsima 100mg Injection 1 vial?

Receiving live vaccines during your treatment with  Remsima 100mg Injection 1 vial is not advised and sometime after your therapy ends, do not receive any live vaccines like MMR, BCG, shingles, etc. In case for some reason, you have received  Remsima 100mg Injection 1 vial during the pregnancy, your newborn child will be affected by this medicine, so avoid your child getting vaccinated for at least 6 months. Discuss with your doctor for more clarity

#13. CAN I RIDE OR DRIVE AFTER TAKING Remsima 100mg Injection 1 vial?

Remsima 100mg Injection 1 vial can affect your vision, so if you are feeling unwell avoid activities like driving a car or riding a bike. Also, avoid operating sharp tools or machinery till it subsides.