Certolizumab

As a monoclonal antibody, Certolizumab is administered via injection to alleviate symptoms of inflammation.

Overview:

Certolizumab functions by reducing the effects of substances within the body which are associated with inflammation. It can be used to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in adults. It has been FDA-approved for use in the United States since 2008 and is typically used as an alternative treatment for patients who do not respond adequately or sufficiently to standard therapies used to treat inflammatory conditions.

It is a prescription-only medicine which is injected underneath the skin. It prevents inflammation which can result from an overactive immune system. In technical terms, it is known as a TNF (tumor necrosis factor) and it is the only biologic treatment for moderate to severe instances of the illnesses mentioned above. Because of its biologic properties, it has been proven to stay within the body for prolonged periods and this helps to fight symptoms of inflammation.

Because Certolizumab affects the immune system, it can potentially lower the ability of the immune system to fight against certain infections. This increases the propensity for serious infections to happen in patients taking the medicine, including issues caused by bacteria, viruses and fungi which find it easier to spread through the body due to a weakened immune system. It is therefore not advisable for patients to begin treatment with this medication if they are currently suffering from any type of infection.

Conditions treated:

  • Crohn’s disease
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis

Type of medicine:

  • Monoclonal antibody specific to TNF-alpha

Side effects:

Along with the required effects, Certolizumab has also been known to cause a number of unwanted side effects. Although not all of these side effects may occur, some of them can cause mild discomfort. Some side effects may even require medical attention. The most common side effects reported by patients undergoing treatment with Certolizumab include the following: bloody or cloudy urine, chills, body aches and pain, bladder pain, coughing, hoarseness, chills, difficulty breathing, painful uriniation, ear congestion, fever, voice loss, nasal congestion, sore throat, sneezing, unusual weakness or tiredness.

As the patient continues to take Certolizumab as prescribed, most (if not all) of these side effects should lessen. If side effects persist over a prolonged period of time or appear to get worse, the patient is advised to contact their doctor as soon as possible. Healthcare providers may be able to offer advice on how to alleviate certain symptoms using over the counter remedies or natural medicines.

Some patients could potentially experience further side effects. These effects are only noticed rarely (albeit often enough to warrant mentioning) and include the following: blistering, bleeding, coldness, burning, feeling of pressure, infection, hives, inflammation, lumps, itching, pain, rash, scarring, redness, soreness, tenderness, ulceration, tingling, discoloration of the skin, warmth at the site of injection, chest pain, cold or flu-like symptoms, pain the ankles/knees, rapid weight gain, stomach issues, pain the arms/legs, tingling in the hands/feet, tightness within the chest, painful red lumps under the skin, diarrhea, feeling of warmth, confusion, coughing or spitting blood, appetite loss, skin rash, swelling of the lymph glands, sudden high fever lasting for months, nausea, aching muscles, general feeling of discomfort, peeling skin, red and irritated eyes, white sports in the mouth, difficulty moving, vomiting, scaling or crusted skin.

The most common side effects associated with this medication are upper respiratory infection, urinary tract infection and a general rash. Up to 18% of patients who experienced side effects while undergoing treatment with Certolizumab experienced one or more of these effects.

Patients who experience any of these side effects to the point of discomfort should contact their doctor. In extreme instances, a healthcare professional may decide to lower the current dosage of Certolizumab or discontinue its use altogether.

Because Certolizumab can potentially cause confusion in patients undergoing treatment with the medicine, it is inadvisable for a person to drive or operate heavy machinery during the early stages of treatment with this drug, until it has been observed that the patient does not suffer from confusion as a side effect.

Some of the more serious side effects associated with Certolizumab include infections, heart failure and malignancies. Patients should be tested for TB prior to beginning treatment with Certolizumab. This is because the medication has a propensity to lower immune system function and this can result in patients picking up serious and potentially fatal infections much easier than normal.

Patients who develop signs of infection, such as fever, sore throat, chills, night sweats, difficulty breathing, painful urination, unusual vaginal discharge or white patches in the mouth should contact their healthcare provider immediately, as this could be a sign that the patient is in the early stages of an infection which could prove problematic.

Dosage:

As with all medicines, it is incredibly important for patients to only take Certolizumab as prescribed by a physician. This means that patients need to avoid taking larger quantities of the drug than advised, and to only take it at the frequency prescribed. In addition to this, patients should be willing to stop taking Certolizumab if advised to do so by a doctor or healthcare professional, even if they still have a supply of the medication remaining.

Certolizumab is available as a solution or lyophilized powder in a pre-filled syringe. Pre-filled syringes can be injected by the patient, although training on how to do this must be provided by a doctor or healthcare professional. Lyophilized powder should only be prepared and administered in a clinical setting by a qualified healthcare provider.

Adult dose for treatment of rheumatoid arthritis:

Adults experiencing inflammation associated with rheumatoid arthritis should take 400mg of Certolizumab subcutaneously (injected under the skin) during the first, third and fifth weeks of treatment, with 200mg administered subcutaneously every other week. As a maintenance dose, 400mg should be administered subcutaneously in patients who manage to obtain a clinical response.

The injection site should be rotated, and where possible the patient or administered healthcare provider should avoid injecting into areas where the skin is bruised, tender, red or hard. When 400mg of the medicine is required, this should be administered as 2 separate subcutaneous injections of 200mg, occurring in separate sites in the abdomen or thigh.

Adult dose for treatment of psoriatic arthritis:

Adults experiencing inflammation associated with psoriatic arthritis should take 400mg of Certolizumab subcutaneously during the first, third and fifth weeks of treatment, with 200mg administered subcutaneously every other week. As a maintenance dose, 400mg should be administered subcutaneously in patients who manage to obtain a clinical response.

Injection sites must be rotated, and injections should not be administered in areas where the skin is bruised, tender, hard or red. When a 400mg dose is required, it should be given as 2 separate injections administered to separate sites in the abdomen or thigh.

Certolizumab can be used as a monotherapy in patients with an intolerance to methotrexate, or when treatment with methotrexate (MTX) is otherwise considered inappropriate. In instances where the patient can be treated with MTX, it should be administered along with Certolizumab for maximum efficacy.

Adult dose for treatment of ankylosing spondylitis:

Adults experiencing inflammation associated with ankylosing spondylitis should take 400mg of Certolizumab subcutaneously during the first, third and fifth weeks of treatment, with 200mg administered subcutaneously every other week. As a maintenance dose, 400mg should be administered subcutaneously in patients who manage to obtain a clinical response.

Injection sites must be rotated, and injections should not be administered in areas where the skin is bruised, tender, hard or red. When a 400mg dose is required, it should be given as 2 separate injections administered to separate sites in the abdomen or thigh.

Adult dose for Crohn’s disease:

Adults experiencing inflammation associated with Crohn’s should take 400mg of Certolizumab subcutaneously during the first, third and fifth weeks of treatment, with 200mg administered subcutaneously every other week. As a maintenance dose, 400mg should be administered subcutaneously in patients who manage to obtain a clinical response.

Injection sites must be rotated, and injections should not be administered in areas where the skin is bruised, tender, hard or red. When a 400mg dose is required, it should be given as 2 separate injections administered to separate sites in the abdomen or thigh.

This medicine should only be used for reducing symptoms of Crohn’s disease and maintaining a clinical response in patients with moderate-severe symptoms who have otherwise responded inadequately to conventional therapies.

Self-administration information:

Although many patients will receive Certolizumab in a clinical setting, as administered by a qualified healthcare professional, some undergoing treatment with the drug may elect to self-administer or may have no choice but to self-administer (those living in a rural area some distance away from a healthcare center, for example).

A subcutaneous injection is a shot which is administered into the layer of fat situated between the muscle and skin. Patients who self-administer this medication should only do so once a healthcare professional is satisfied they are able to inject without posing a risk to themselves.

There are four sites on the body where a subcutaneous injection can be administered:

  • Abdomen – an injection may be given below the waist, just about the hip bone and approximately two inches away from the belly button. Patients should avoid injecting into the belly button.
  • Thigh – patient should uncover the entire leg before finding the area situated halfway between the knee and hip, to the side. This area should be grasped to ensure 1 to 2 inches of skin can be pinched before administration, to ensure adequate subcutaneous area exists.
  • Lower back – the back should be uncovered from the waist down to the top of the buttocks. The patient should imagine a line which runs across the back just above the crack between buttocks. Injections may be given below the waist, but above this line. Injections should be administered halfway between the side and the spine.
  • Upper arm – patients may struggle to administer an injection in their own upper arm, however, this information is useful in the event of requiring another person to administer it. The arm should be uncovered to the shoulder. The administrating individual should find the area between the shoulder and elbow and gently grasp the skin between the thumb and first two fingers. If 1 to 2 inches of skin can be grasped, this area is safe to administrate.

Patients are advised to keep track of where injections are given, keeping a detailed list of the sites available for use, along with the date, time and site location every time a subcutaneous injection of Certolizumab is administered.

Injection sites should be rotated. It is important to use a different site every time an injection is administered as this helps to prevent scars and changes in the skin. Sites where injections are administered should be at least one inch away from previous injection areas. For further advice on choosing injection sites, patients are advised to contact their healthcare provider.

Subcutaneous injections can be administered at a 45-degree angle or administered straight-in at 90 degrees. If two inches of skin can be grasped between thumb and forefinger, the injection should be given straight-in. If only one inch can be grasped, the injection should be administered at a 45-degree angle. Patients can use the following recommendations to successfully administer an injection of Certolizumab:

  • Open an alcohol wipe, and use it to clean the area where the patient plans to inject. This area should be allowed to dry prior to injection.
  • The patient should now prepare the needle by holding the syringe with their strongest hand and pulling the cover off with their other hand. The syringe should then be placed between thumb and forefinger, with the barrel of the syringe resting on the second finger.
  • With their free hand, the patient should grasp the area of skin in which they plan to inject.
  • The needle should then be inserted into the skin. The syringe barrel should be held tightly, with the wrist used to inject the needle into the skin. Once the needle is sufficiently in, the plunger should be pushed down to inject the medicine.
  • After administration, the needle must be removed at the same angle of entrance. The injected area should be wiped with a gauze pad.

Patients are advised against taking double doses, as this can lower the immune system and further increase serious side effects. If a patient misses a dose, they are advised to take the missed dose if only a short period of time has elapsed since the planned dose. If it is closer to the time of the next dose, the patient should simply omit the missed dose and take the next planned dose as normal, before continuing with the medication administration schedule as prescribed.

If the patient experiences any signs of an overdose, including (but not limited to) extremely fast or slow heartbeat, difficult or shallow breathing, seizures, flushed skin or loss of coordination, they are advised to contact their local poison control center on 1800-222-1222 or emergency services on 911.

Interactions:

All drugs have the potential to interact with other medicines or chemicals within the human body. These interactions have the potential to change the effects of one or more medications, and in some instances, some interactions can give rise to potentially harmful or even fatal side effects. Because of this, it is incredibly important for patients to keep a full, detailed list of all medicines they are currently undergoing treatment with. This extends to over the counter remedies, complementary medicines, vitamins and herbal supplements.

Below is a partial list of drugs known to majorly interact with Certolizumab. Patients who are currently taking any of these medicines are advised to notify their doctor or healthcare provider prior to starting treatment with this medicine:

  • Hydrocortisone
  • Altretamine
  • Alunbrig
  • Alkeran
  • Abatacept
  • Anakinra
  • Abraxane
  • Actemra
  • Aristospan
  • Aldesleukin
  • Azacitidine
  • Azathioprine
  • Basiliximab
  • Baycadron
  • Belatacept
  • Belimumab
  • Bendamustine
  • Bosutinib
  • Brigatinib
  • Budesonide
  • Busulfan
  • Cabazitaxel
  • Cobimetinib
  • Canakinumab
  • Colocort
  • Copanlisib
  • Capectabine
  • Copanlisib
  • Clofarabine
  • Clozapine
  • Cytarabine
  • Cosyntropin
  • Celestone
  • Dacarbazine
  • Daclizumab
  • Docetaxel
  • Fludarabine
  • Everolimus
  • Finolimod
  • Floxuridine
  • Folotyn
  • Golimumab
  • Gemtuzumab
  • Ganciclovir
  • Hexadrol
  • Hydroxyurea
  • Ibritumomab
  • Infliximab
  • Idarubicin
  • Imatinib
  • Ixazomib
  • Jevtana
  • Kyprolis
  • Kevzara
  • Levamisole
  • Linezolid
  • Methotrexate
  • Midostaurin
  • Mitomcycin
  • Melphalan
  • Mercaptopurine
  • Mitoxantrone
  • Nilotinib
  • Nirapirib
  • Nelarabine
  • Osimertinib
  • Ofatumumab
  • Paclitaxel
  • Prednisolone
  • Primaquine
  • Procainamide
  • Procarbazine
  • Prlatrexate
  • Romidepsin
  • Rituximab
  • Ribociclib
  • Riloacept
  • Ruxolitinib
  • Sarilumab
  • Sirolimus
  • Streptozocin
  • Tacrolimus
  • Topotecan
  • Trastuzumab
  • Thalidomide
  • Ustekinumab
  • Vedolizumab
  • Venetoclax
  • Vinorelbine
  • Xeloda
  • Zidovudine
  • Zodex

In addition to advising their doctor of any allergies and drugs currently being used, the patient should also discuss their medical history and notify the doctor if they are sporadically or routinely using alcohol, smoking or taking recreational drugs. This is because some of these activities can affect the immune system, making the body more susceptible to infection when the patient is undergoing treatment with Certolizumab.

Warnings:

Patients with certain health conditions may be advised against using Certolizumab or may be advised to use a reduced dose of the medication.

The potential to develop lymphoma and/or other cancers may be increased in those taking TNF-blocking medicines such as Certolizumab. In children and young adults undergoing use with this medication, there have been reported cases of cancers which do not usually occur in people of these ages. For these reasons, Certolizumab is not approved for use in pediatric patients.

Some patients undergoing treatment with Certolizumab have been known to develop a rare form of cancer known as hepatosplenic T-cell lymphoma. This form of cancer often results in death, and the majority of people who developed this cancer and subsequently died were young males suffering from ulcerative colitis or Crohn’s disease while being treated with Certolizumab and another medicine called Imuran.

The use of Certolizumab can increase the propensity for certain types of skin cancer to develop. Patients are advised to inform their healthcare provider immediately if they notice any changes in the appearance of their skin, including growths, during or after treatment with Certolizumab.

Certolizumab can potentially cause heart failure or contribute towards worsening heart failure in some patients. If a patient experiences shortness of breath, sudden weight gain and/or swelling of the ankles and feet, they should contact a doctor immediately.

Patients with a weakened immune system (such as this living with diabetes or HIV) are at a higher risk of developing infections when undergoing treatment with Certolizumab. Therefore, great care should be taken by at-risk patients, many of whom may benefit from receiving the medication under observation in a clinical setting,

Storage:

Certolizumab should be kept refrigerated in its original carton, preferably in a dedicated medical fridge. It should be stored out of reach of children and pets. In addition to this, the manufacturer recommends that Certolizumab should be kept out of direct light and should not be frozen.

Each pre-filled syringe is for single-use only, and should be disposed of after one use, even if medicine remains inside it. Patients are advised so followed local and/or state laws regarding the disposal of used needles or “sharps”. Puncture-proof sharps containers should be used for disposal. These can be obtained from a pharmacist, who may also be able to exchange or dispose of used needles.

Summary:

Certolizumab is an effective treatment for inflammatory conditions such as rheumatoid arthritis, Crohn’s disease, psoriatic arthritis and ankylosing spondylitis. It is a monoclonal antibody which functions against tumor necrosis factor alpha. While it is useful in treating certain painful conditions, patients should be aware that there are risks associated with this medicine and should discuss their medical history with a doctor to ascertain whether this medicine is a suitable treatment.

When used correctly, Certolizumab helps to alleviate pain and provides patients with the means to live a more fulfilling life. However, significant side effects are known to occur in at least 2 per cent of patients who undergo treatment with the drug, as it has a propensity to affect the immune system. Therefore, doctor and patient need to work together in order to eliminate risks and help the patient to get the most out of Certolizumab use.

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Last Reviewed:
December 23, 2017
Last Updated:
December 22, 2017
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