What is Actemra ACTPen?

Actemra ACTPen is used to treat a variety of conditions in both adults and children. Primarily, Actemra ACTPen is used to treat adults with moderate to severe rheumatoid arthritis who have not responded to other medications. It also treats giant cell arteritis (GCA) to slow declining lung function caused by interstitial lung disease and to hospitalized patients with COVID-19 who have received steroid medicine or need supplemental oxygen.

For children over the age of 2 and adults, Actemra ACTPen treats systemic juvenile idiopathic arthritis (SJIA), polyarticular juvenile idiopathic arthritis (PJIA), and severe cytokine release syndrome. It has the active ingredient antibody tocilizumab and is manufactured by Genentech USA.

How does Actemra ACTPen work?

Actemra ACTPen helps by reducing swelling in the patient's blood vessels so blood flows more easily. Tocilizumab is an interleukin-6 (IL-6) receptor antagonist drug that works by blocking the swelling substance IL-6 in the body. As an IL-6 inhibitor, Actemra ACTPen should help reduce the swelling and pain from rheumatoid arthritis.

What doses of Actemra ACTPen are available?

The Actemra ACTPen dosage will depend on a few factors, including the type and severity of the condition, body weight, preexisting conditions, and injection mechanism. Usually, Actemra ACTPen is given every 1 to 4 weeks. If the medication is being used to treat PJIA in children, it is usually given once every 2 or 3 weeks. For SJIA, it is usually given every 1 or 2 weeks. For CRS, usually, one dose is given.

The medication is given as a subcutaneous injection or an intravenous (IV) infusion, depending on your condition. The subcutaneous injection is an injection under your skin that comes as either a prefilled syringe or single-dose autoinjector and is available as 162 milligrams/0.9 milliliter (mg/mL). The intravenous infusion goes into the patient's vein and is given over a period of time. It comes in one strength: 20mg/mL. For systemic sclerosis-associated interstitial lung disease (SSc-ILD), Actemra is given subcutaneously.

How do you use Actemra ACTPen?

Follow all directions on the prescription label, your medication guide, or instructions for use that are given. The dosage and frequency depend on what disease the medication is treating and your healthcare provider's instructions. When injected, the medicine is usually given slowly over an hour into the vein. Ask your doctor if you do not understand the injection instructions.

Ensure the medicine does not look cloudy, has changed color, has particles, or has reached the expiration date. Call your pharmacist if you suspect anything to be wrong. Do not inject into the same place twice. Recommended injection sites include the front of the thigh, abdomen, or upper arm. Ask a caregiver for help, especially at the beginning.

Remove the medicine from the refrigerator, and let it warm to room temperature to avoid discomfort. Autoinjectors should be warmed for 45 minutes; prefilled syringes should be warmed for 30. Do not reuse any needles, prefilled syringes, or ACTPen autoinjectors. After injection, place the device into a puncture-proof "sharps" container. Dispose in accordance with state or local laws, even if there is medicine still left inside. Make sure to follow up with your doctor about any necessary medical tests, especially liver function tests that should be completed to ensure your body is working correctly after the treatment.

What are the side effects of Actemra ACTPen?

The most common side effects of Actemra ACTPen in clinical trials compared to placebo include:

Runny or stuffy nose, sore throat, or sinus pain
Headache
Increased blood pressure (hypertension)
Abnormal liver function tests
Injection site reactions, including pain, swelling, burning, or irritation

Rarely, Actemra ACTPen may cause some serious side effects, including:

Increased risk of serious infections including tuberculosis
Hole or tear (perforation) in your stomach or intestines
Unusual bleeding
Liver disease (persistent nausea/vomiting, loss of appetite, yellowing of your eyes/skin, dark urine, right-sided stomach pain)
Stomach cramps (severe), bloating, constipation or diarrhea
Serious allergic reactions, including trouble breathing, swelling of your lips, tongue, or face, and feeling dizzy or faint
High cholesterol levels
Nervous system problems such as multiple sclerosis

Contact your healthcare professional or rheumatology team for medical advice about any possible adverse effects you experience while taking Actemra ACTPen. You can report your adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Actemra ACTPen drug interactions

When Actemra ACTPen is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Actemra ACTPen include:

Anakinra
Abatacept
Etanercept
Certolizumab
Golimumab
Infliximab
Rituximab
Adalimumab

Boxed warnings

Actemra can cause serious infections that lead to hospitalization or, in severe cases, death. In clinical studies, patients who took methotrexate, a disease-modifying antirheumatic drug (DMARD), corticosteroids, or prednisone all had a higher chance of infection. Stop taking Actemra if any serious infection develops, and until it is controlled.

The following is a list of reported infections:

Active tuberculosis. Unless the patient has COVID-19, patients should be tested before Actemra use and during therapy for latent tuberculosis. Treatment should be started prior to Actemra.
Any invasive fungal infections. Those include aspergillosis, pneumocystis, and candidiasis.
Other viral or bacterial infections.

Risk should be assessed carefully prior to taking Actemra if patients are susceptible to chronic or recurrent infections. During and after treatment of Actemra, patients should also be closely monitored for signs and symptoms of infection. Even if patients tested negative for latent tuberculosis prior to therapy, tests should occur to ensure patients are not developing tuberculosis.

Actemra ACTPen precautions

Be very mindful that Actemra ACTPen is used as an injection, and infections can happen easily. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

Been exposed to or had tuberculosis, or if you have recently traveled
An active or chronic infection
Diabetes
Diverticulitis or ulcers in your stomach or intestines
Liver disease
Low platelet count
HIV, or weak immune system
Hepatitis B (or if you carry the virus)
Cancer
If you are receiving or scheduled to receive any vaccines
Pregnant or breastfeeding. This might alter your baby’s vaccination schedule.

Is there a generic available for Actemra ACTPen?

Currently, there is no generic available for Actemra ACTPen.

How do you store Actemra ACTPen?

Store Actemra ACTPen in the original container in a refrigerator between 36°F to 46°F (2ºC to 8ºC). Keep dry and out of sunlight. Do not freeze. After removing from the refrigerator, the syringe and or autoinjector can be stored for up to two weeks at or below 86°F (30°C).