Training comes first
The Ozempic® Medication Guide says your healthcare provider should show you how to use the pen before you use it for the first time [1]. The Wegovy®, Mounjaro® and Zepbound® labels go further: prescribers are asked to tell you which presentation you will get, train you for that specific one, and retrain you and point you to the new IFU if the prescribed device changes [2][3][4]. The Trulicity® label asks for training on injection technique before the first dose [5].
After training, the labels allow self-injection when the healthcare provider judges that you can do it properly, with some exceptions. The Mounjaro® and Zepbound® KwikPen® and the Wegovy® FlexTouch® are not recommended for self-injection by people with visual impairment, and the Mounjaro® KwikPen® not by children [2][3][4]. The Saxenda® and Ozempic® syringe instructions ask anyone who cannot read the dose counter or has vision problems to inject only with help from a trained person [1][6].
What an IFU is
The FDA describes Instructions for Use as patient labeling for medicines with complicated or detailed use instructions, including medicines given with an autoinjector or syringe. It gives step-by-step written and visual instructions on using, preparing, giving, handling, storing and disposing of the medicine [13].
Each device has its own IFU, and the IFU changes with the device, not only with the medicine. Ozempic® has separate IFUs for its 0.25 mg or 0.5 mg pen, its 1 mg pen, its 2 mg pen and its prefilled syringe [1]. Wegovy® has one for the single-dose pen, one for the Wegovy® HD 7.2 mg pen, one for the FlexTouch® and one for the syringe [2]. Lilly publishes separate IFUs for the tirzepatide single-dose pen, KwikPen® and vials [8][9][10].
Device types, brand by brand
The table groups the devices in the current US labels by how a dose is given. It summarises the documents for comparison; the IFU in your own carton is the one to follow.
| Device type | Brands and forms | What the instructions describe |
|---|---|---|
| Single-dose pen, needle hidden [2][5][8] | Wegovy® single-dose pen and Wegovy® HD; Mounjaro® and Zepbound® single-dose pens; Trulicity® pen | The dose is preset; the pen is placed on the skin, the injection runs by itself and the pen is discarded after one use [2][8][11] |
| Single-dose prefilled syringe [1][2] | Ozempic® 0.25 mg, 0.5 mg and 1 mg syringes; Wegovy® single-dose syringes | The needle is attached; the skin is pinched, the needle goes in at 45 degrees and the plunger is pushed all the way down [1][2] |
| Multi-dose pen, new needle each time [1][2][6][7] | Ozempic® pens (0.25 or 0.5 mg, 1 mg, 2 mg); Wegovy® FlexTouch®; Saxenda®; Victoza® | A dose selector sets the dose, the flow is checked with each new pen, and the dose button is held after the counter returns to 0 [1][2][6][7] |
| KwikPen®, four fixed doses [3][4][9] | Mounjaro® KwikPen®; Zepbound® KwikPen® | A new pen needle is attached, the pen is primed before every weekly dose, the knob is turned until it stops and held in for a count of 5 [9] |
| Vial with a separate syringe [3][4][10] | Mounjaro® and Zepbound® single-dose and multi-dose vials | The dose is drawn up with a syringe able to measure 0.5 mL or 0.6 mL, with a new syringe and needle every time [3][4][10] |
Single-dose pens
A single-dose pen is used once and thrown away. The Wegovy® single-dose pen IFU describes the dose as already set, with the needle hidden under a needle cover. The injection starts when the cover is pressed firmly against the skin, and a yellow bar in the window moves while the dose goes in; the needle cover locks when the pen is lifted away [2]. The EU document adds that the injection takes about 5 to 10 seconds [12].
The Mounjaro® and Zepbound® single-dose pens work in a different order. The gray base cap comes off, the clear base sits flat on the skin, the lock ring is turned to unlock, and the purple button is pressed and held for up to 10 seconds. A first click means the injection has started and a second that it is complete; the dose went in if the gray plunger is visible [8][15]. Trulicity® comes in cartons of four single-dose pens [5]; its EU instructions describe a green button that inserts the needle, gives the dose and pulls the needle back, with a second click about 5 to 10 seconds later [11].
Multi-dose pens you dial
The Ozempic® IFU calls its pen a prefilled, single-patient-use, dial-a-dose pen: you attach a new needle for each injection and turn a dial to select the dose. Each Ozempic® pen delivers doses only in its own steps: 0.25 mg or 0.5 mg, 1 mg, or 2 mg [1]. The Wegovy® FlexTouch® holds four doses and can only select 2.4 mg [2]. The Saxenda® pen holds 18 mg of liraglutide and selects 0.6, 1.2, 1.8, 2.4 or 3 mg, and the Victoza® pen delivers 0.6, 1.2 or 1.8 mg [6][7].
In the EU, the 7.2 mg Wegovy® dose can be given as one 7.2 mg injection or, depending on the device, as three 2.4 mg injections, placed in the same body area at least 5 cm apart [12]. “Single-patient-use” matters for all of these pens: the labels say a multi-dose pen must never be shared, even with a new needle, because of the risk of passing on blood-borne infections [1][2][6][7].
The KwikPen®
The Mounjaro® and Zepbound® KwikPen® holds four fixed weekly doses plus a little extra volume for priming [3][4]. Unlike the Ozempic® pen, it is primed before every weekly injection: the knob is turned to the prime position, the pen is held needle-up and the knob is pushed in for a count of 5 until a drop appears at the needle tip [9].
For the dose itself, the knob is turned all the way until it stops and the dose icon shows in the window; the IFU says not to count clicks. The knob is then pushed in and held for a count of 5. After the fourth dose the pen will not let you dial a full one, and the IFU says not to inject the leftover medicine or move it into a syringe [9]. Pen needles are not included in the carton [9].
The parts of a dial-a-dose pen
- Pen cap: protects the medicine from light between uses.
- Pen window: lets you check that the medicine looks right before use. The Ozempic® IFU describes it as clear and colorless [1].
- Dose selector: the dial you turn to set the dose.
- Dose counter and dose pointer: show the dose selected. The IFU says to read the counter, not to count the clicks [1].
- Dose button: pressed and held to inject.
- Flow check symbol: used once with each new pen to confirm medicine comes out of the needle [1].
- Needle with a paper tab, an outer cap and an inner cap: both caps have to come off, or no medicine is injected [1].
What the IFU walks through
The Ozempic® pen IFU is organised in five steps: preparing the pen with a new needle, checking the flow with each new pen, selecting the dose, injecting, and what to do afterwards. It also explains how to see how much medicine is left, how to recognise a blocked or damaged needle, and why the dose button is held down for a slow count of 6 after the counter returns to 0 [1]. The Saxenda® and Victoza® pen instructions use the same count of 6 [6][7].
The closing pages cover storage, caring for the pen and disposal. The IFU says never to use a syringe to draw medicine out of the pen, to keep the pen away from heat and cold, and to discard an in-use Ozempic® pen after 56 days even if medicine remains. If the pen is dropped, it asks for a new needle and a flow check before the next injection [1].
Needles and disposal
The Ozempic® and Wegovy® FlexTouch® IFUs say a new needle is used for every injection; reusing needles raises the risk of contamination, infection, leakage and blocked needles that give the wrong dose [1][2]. Used pens and needles go into an FDA-cleared sharps container. The Zepbound® KwikPen® IFU is a little different: the needle goes into the sharps container, and the pen, once the needle is removed, may go in household trash or the sharps container [9].
The FDA describes a two-step approach: put sharps into a container straight after use, then get rid of the container according to your community guidelines once it is about three-quarters full [14].
Keeping track of doses left in a pen
With a multi-dose pen, it is easy to lose count. The Wegovy® FlexTouch® IFU suggests using the table inside the carton lid to track injections used and doses remaining [2], and the Zepbound® KwikPen® IFU ends with a medication calendar for writing your injection day and the date of each of the four doses [9]. A dose log does the same job and adds the time and injection site.
Ozempic®, Wegovy®, FlexTouch®, NovoFine®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk A/S. Mounjaro®, Zepbound®, KwikPen® and Trulicity® are registered trademarks of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Novo Nordisk or Eli Lilly and Company.